Split (3)

train · 14.2k rows

id stringlengths 4 8	query stringlengths 571 17.5k	answer stringlengths 12 3.68k
MS2600	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: To assess the effects of crystalloid and colloid resuscitation on hemodynamic response and on lung water following thermal injury , 79 patients were assigned r and omly to receive lactated Ringer 's solution or 2.5 % albumin-lactated Ringer 's solution . Crystalloid-treated patients required more fluid for successful resuscitation than did those receiving colloid solutions ( 3.81 vs. 2.98 ml/kg body weight/% body surface burn , p < 0.01 ) . In study phase 1 ( 29 patients ) , cardiac index and myocardial contractility ( ejection fraction ' and mean rate of internal fiber shortening , Vcf ) were determined by echocardiography during the first 48 hours postburn . Cardiac index was lower in the 12-to 24-hour postburn interval in the crystalloid group , but this difference between treatment groups had disappeared by 48 hours postburn . Ejection fractions were normal throughout the entire study , while Vcf was supranormal ( p < 0.01 vs. normals ) and equal in the two resuscitation groups . In study phase 2 ( SO patients ) , extravascular lung water and cardiac index were measured by a st and ard rebreathing technique at least daily for the first postburn week . Lung water remained unchanged in the crystalloid-treated patients ( p > 0.10 ) , but progressively increased in the colloid-treated patients over the seven day study ( p < 0.0001 ) . The measured lung water in each treatment group was significantly different from one another ( p < 0.001 ) . Cardiac index increased progressively and identically in both treatment groups over the study period ( p < 0.01 ) . These data refute the existence of myocardial depression during postburn resuscitation and document hypercontractile left ventricular performance . The addition of colloid to crystalloid resuscitation fluids produces no long lasting benefit on total body blood flow , and promotes accumulation of lung water when edema fluid is being reabsorbed from the burn wound In a prospect i ve r and omized trial of 16 patients undergoing abdominal vascular reconstructive procedures , changes in plasma volume , serum oncotic pressure ( pis ) , serum albumin and total protein concentration , alveolar to arterial oxygen tension differences ( AaDO2 , FIO2 = 1.0 ) , creatinine clearance , body weight , and fluid and sodium intake were examined . By r and om assignment patients received either an albumin- or a sodium-rich intraoperative fluid regimen . Pulmonary arteriovenous admixture was significantly less in the albumin group ( n = 7 ) than in the electrolyte group ( n = 9 ) on the first postoperative day . The change in AaDO2 correlated positively with the total sodium intake in the electrolyte group . Despite the larger fluid load and significantly greater gain of body weight , patients in the electrolyte group had a postoperative plasma volume significantly lower than the preoperative value . Postoperative values of albumin concentration , circulating albumin mass and pis were significantly greater in the albumin group in comparison to the electrolyte group . Creatinine clearance values were not different between the two groups . The change in pis correlated significantly with sodium intake and circulating albumin mass . Pulmonary shunting and expansion of the extracellular fluid volume may be minimized without adverse effects on renal function by administration of fluids rich in albumin in preference to sodium OBJECTIVE To determine whether replacement of human albumin will improve a patient 's prognosis . DESIGN A r and omized , double-blind , controlled study in which 25 g of human albumin vs. placebo was administered intravenously daily . SETTING A university-affiliated hospital . PATIENTS Thirty-six patients with hypoalbuminemia ( serum albumin of < 2.5 g/dL ) , receiving total parenteral nutrition . None of the patients had known cancer , cirrhosis , or nephrotic syndrome . INTERVENTIONS Each patient received at least 6 days of therapy ( 6 to 24 days of albumin ; 7 to 32 days of placebo ) . Four subjects were excluded from the study since they received therapy for < 6 days . One patient was excluded from the study after nephrotic syndrome was identified . Albumin metabolic rates for those patients receiving albumin were estimated using the formula : Metabolism of albumin = 25 g/day + ( albumin 1 - albumin 2)(Vd)/days , where albumin 1 and 2 are the serum albumin concentrations ( g/L ) at the beginning and end of the serum sampling intervals , respectively ; Vd is the volume of distribution ( L ) ; and days relates to the number of days of the sampling interval . MEASUREMENTS AND MAIN RESULTS Sixteen patients received albumin ; 15 patients received placebo . One patient receiving placebo and two patients receiving albumin died within 30 days . One patient who received placebo and three patients who received albumin developed sepsis or bacteremia ; four patients who received placebo and seven patients who received albumin developed pneumonia during the study ( NS ) . The serum albumin increased in all patients receiving intravenous albumin , but one patient received intravenous albumin for only 6 days . The mean serum albumin concentration increased by 1.42 g/dL in the albumin patients , and increased by 0.29 in the placebo patients ( p < .0001 by unpaired t-test ) . Mean initial albumin metabolism was 17.4 g/day ( 0.3 g/kg/day ) . At the end of therapy , albumin metabolism was 20.5 g/day ( 0.36 g/kg/day ) ( paired t-test , p = .4 , NS ) . CONCLUSIONS a ) The administration of intravenous albumin to hypoalbuminemic patients receiving total parenteral nutrition does not improve morbidity or mortality . b ) Albumin metabolic rates , initially related to the catabolic state , are high ; later , these rates are high related to filling of the albumin space and gluconeogenesis . c ) On the basis of the high albumin catabolic rates at the end of the infusion , doses of albumin of < 25 g/day might be sufficient to replace albumin stores The effects of concurrent administration of albumin with total parenteral nutrition were studied in 12 premature newborns ( birth weight 1.26 + /- 0.1 kg [ mean + /- SEM ] and gestational age 30 + /- 0.8 weeks [ mean + /- SEM ] ) compared with a control group of 12 premature newborns ( birth weight 1.17 + /- 0.2 kg and gestational age 29 + /- 0.1 weeks ) who received total parenteral nutrition . All newborns had a plasma albumin level below 3 g/dL and were in cardiorespiratory distress requiring assisted ventilation . Albumin supplementation of total parenteral nutrition result ed in a sustained increase in serum albumin concentration as well as increased mean arterial blood pressures in the study group . Slow albumin infusion had no observed effect on the severity of respiratory distress . Study group infants regained birth weight earlier than control group infants . These data suggest that the concurrent administration of albumin may be clinical ly beneficial in critically ill newborn infants Patients with colorectal cancer undergoing elective surgery with resection of the tumour and primary anastomosis were r and omly allocated into two groups . 29 patients received a total of 60 - 75 g of albumin postoperatively , 30 patients received no albumin and served as controls . The two groups were comparable with respect to age and sex of the patients and stage of growth of the tumour . The patients who received albumin had a significantly lower preoperative serum albumin concentration . On day 4 after the operation the serum albumin concentrations of the control patients and the patients who received albumin were 20 % and 5 % lower , respectively , than the preoperative value . Eight patients of the albumin group and 5 of the control group developed postoperative complications . There was no significant difference in the postoperative clinical course between the two groups . Preoperative serum albumin levels did not differ between patients who developed postoperative complications and those who had an uneventful postoperative course whether or not they received albumin postoperatively . The present study does not confirm earlier results indicating that serum albumin alone is of prognostic value for the postoperative course following colorectal surgery . Furthermore , the postoperative course is not improved by addition of albumin postoperatively and hence albumin should be given in this situation only when its specific oncotic effect is required Colloid osmotic pressure ( COP ) was followed postoperatively in 55 r and omized patients . After minor operations and short-term infusion therapy only small changes of the COP could be observed and it was concluded that after such operation COP measurement is unnecessary . After major surgical interventions , however , COP measurement gave valuable hints . It was shown that even in the case of moderate blood loss replaced by crystalloids an abnormally low COP did not occur . The same applied also to preoperative hemodilution . It was unnecessary to substitute the withdrawn blood with a colloid solution . In addition , COP measurement helped to avoid expensive albumin administrations and indicated colloid overload in cases of pulmonary edema Albumin replacement to correct hypoalbuminemia in critically ill patients has been controversial . This study was a prospect i ve , r and omized trial of 25 % albumin administration in 40 hypoalbuminemic ( serum albumin , less than 25 g/L [ 2.5 g/dL ] ) , critically ill patients . The treatment group ( 18 patients ) received 25 % albumin supplementation to achieve and maintain serum albumin levels of 25 g/L ( 2.5 g/dL ) or greater , while the nontreatment group ( 22 patients ) received no concentrated albumin . There was no clinical benefit from albumin therapy when assessing mortality ( 39 % vs 27 % , treatment vs control ) or major complication rate ( 89 % vs 77 % of patients ) . There were also no significant differences in length of hospital stay , intensive care unit stay , ventilator dependence , or tolerance of enteral feeding , despite significant elevations of albumin in the treatment group . The costly use of exogenous albumin as treatment for hypoalbuminemia in this patient population does not appear to be justified The effect of decreased colloid oncotic pressure , as seen in hypoalbuminemia and hypoproteinemia , upon intestinal function has been well delineated in the surgical literature . Patients undergoing abdominal aortic aneurysm resection or aortoiliac or aortofemoral bypass grafts are almost uniformly hypoalbuminemic postoperatively ; with these two facts in mind , a prospect i ve , r and omized clinical study was undertaken to identify the role of serum albumin concentration on the length of postoperative ileus in this population . The main hypothesis was that patients whose albumin levels dropped below 3.5 gm/dL would have a more prolonged postoperative hospital course as a result of delay in return of bowel function when compared with those patients in whom the low albumin levels were exogenously acutely replenished to > 3.5 gm/dL. Albumin was replaced to a level greater-than or equal to 3.5 g/dL in one group of 37 patients ( AR ) , with a control group of 32 patients ( NR ) not receiving any albumin . Return of bowel function was measured by the postoperative day that flatus was documented , as well as the postoperative day oral intake was resumed . Mean values were determined for each group , and t tests did not reveal a significant difference in postoperative day of flatus ( AR mean = 4.06 days , NR mean = 4.16 days ) or postoperative day of oral intake ( AR mean = 4.0 , NR mean = 3.75 ) . Additional comparisons between the groups involving the number of postoperative days until a regular diet was begun ( AR mean = 6.06 , NR mean = 5.48 ) and length of postoperative hospital stay ( AR mean = 9.16 , NR mean = 8.43 ) failed to reveal significant differences . ( ABSTRACT TRUNCATED AT 250 WORDS The effects on fluid balance , pulmonary tunctions and economics were evaluated in a r and omized comparison of one colloid free and three colloid containing fluid regimens , for 48 hours during and after coronary artery‐bypass ( CAB ) surgery Cardiac output and pulmonary wedge pressure ( PWP ) were used to evaluate the end point of fluid resuscitation in 20 patients suffering from multiple trauma and shock . Eleven patients received crystalloid resuscitation and nine patients received colloid resuscitation . Fifteen of 20 patients had an adequate cardiac output at the termination of resuscitation , but but only six of these patients had a PWP above 10 mm Hg . There was no significant correlation between left ventricular stroke work index and PWP in these patients , either at the completion of resuscitation or during the following three days . Five patients did not achieve adequate cardiac output and four of these patients died , suggesting that cardiac output was the most important criterion for adequate resuscitation . If the goal of fluid resuscitation is to achieve an adequate cardiac output , then PWP was not a reliable guide . Furthermore , using both cardiac output and PWP as a guide to fluid resuscitation of our patients , we found that the type of fluid ( crystalloid or colloid ) for resuscitation did not influence the course of respiratory distress in these patients up to three days following resuscitation Hemodynamic , pulmonary , and renal variables were measured in 24 patients scheduled for major abdominal aortic operations . Control values were obtained before preoperative medications were given . All patients received 5 % dextrose in Lactated Ringer 's solution intraoperatively . Postoperatively , group 1 patients received 5 % dextrose in water plus albumin , group 2 received 5 % dextrose in 0.45 sodium chloride solution , and group 3 received 5 % dextrose in lactated Output:	CONCLUSIONS There is no evidence that albumin administration reduces mortality in critically ill patients with hypovolaemia , burns , or hypoalbuminaemia and a strong suggestion that it may increase mortality .
MS2601	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Studies of the effects of physical fitness on cognition suggest that exercise can improve cognitive abilities in healthy older adults , as well as delay the onset of age-related cognitive decline . The mechanisms for the positive benefit of exercise and how these effects interact with other variables known to influence cognitive function ( e.g. , involvement in cognitive activities ) are less well understood . The current study examined the associations between the physical fitness , cerebrovascular blood flow regulation and involvement in cognitive activities with neuropsychological function in healthy post-menopausal women . Methods : Forty-two healthy women between the ages of 55 and 90 were recruited . Physical fitness ( V˙O2 max ) , cerebrovascular reserve ( cerebral blood flow during rest and response to an increase in end-tidal ( i.e. , arterial ) PCO2 ) , and cognitive activity ( self-reported number and hours of involvement in cognitive activities ) were assessed . The association of these variables with neuropsychological performance was examined through linear regression . Results : Physical fitness , cerebrovascular reserve and total number of cognitive activities ( but not total hours ) were independent predictors of cognitive function , particularly measures of overall cognitive performance , attention and executive function . In addition , prediction of neuropsychological performance was better with multiple variables than each alone . Conclusions : Cognitive function in older adults is associated with multiple factors , including physical fitness , cerebrovascular health and cognitive stimulation . Interestingly , cognitive stimulation effects appear related more to the diversity of activities , rather than the duration of activity . Further examination of these relationships is ongoing in a prospect i ve cohort study Although within-person comparisons allow direct assessment s of change , some of the observed change may reflect effects associated with prior test experience rather than the processes of primary interest . One method that might allow retest effects to be distinguished from other influences of change involves comparing the pattern of results in a longitudinal study with those in a study with a very short retest interval . Three short-term retest studies with moderately large sample s of adults are used to provide this type of reference information about the magnitude of change , test-retest correlations , reliabilities of change , and correlations of the change in different cognitive variables with each other , and with other types of variables Abstract This study tested the common assumption that , to be most effective , working memory ( WM ) training should be adaptive ( i.e. , task difficulty is adjusted to individual performance ) . Indirect evidence for this assumption stems from studies comparing adaptive training to a condition in which tasks are practice d on the easiest level of difficulty only [ cf . Klingberg ( Trends Cogn Sci 14:317–324 , 2010 ) ] , thereby , however , confounding adaptivity and exposure to varying task difficulty . For a more direct test of this hypothesis , we r and omly assigned 130 young adults to one of the three WM training procedures ( adaptive , r and omized , or self-selected change in training task difficulty ) or to an active control group . Despite large performance increases in the trained WM tasks , we observed neither transfer to untrained structurally dissimilar WM tasks nor far transfer to reasoning . Surprisingly , neither training nor transfer effects were modulated by training procedure , indicating that exposure to varying levels of task difficulty is sufficient for inducing training gains Background A variety of studies have demonstrated gains in cognitive ability following cognitive training interventions . However , other studies have not shown such gains , and questions remain regarding the efficacy of specific cognitive training interventions . Cognitive training research often involves programs made up of just one or a few exercises , targeting limited and specific cognitive endpoints . In addition , cognitive training studies typically involve small sample s that may be insufficient for reliable measurement of change . Other studies have utilized training periods that were too short to generate reliable gains in cognitive performance . Methods The present study evaluated an online cognitive training program comprised of 49 exercises targeting a variety of cognitive capacities . The cognitive training program was compared to an active control condition in which participants completed crossword puzzles . All participants were recruited , trained , and tested online ( N = 4,715 fully evaluable participants ) . Participants in both groups were instructed to complete one approximately 15-minute session at least 5 days per week for 10 weeks . Results Participants r and omly assigned to the treatment group improved significantly more on the primary outcome measure , an aggregate measure of neuropsychological performance , than did the active control group ( Cohen ’s d effect size = 0.255 ; 95 % confidence interval = [ 0.198 , 0.312 ] ) . Treatment participants showed greater improvements than controls on speed of processing , short-term memory , working memory , problem solving , and fluid reasoning assessment s. Participants in the treatment group also showed greater improvements on self-reported measures of cognitive functioning , particularly on those items related to concentration compared to the control group ( Cohen ’s d = 0.249 ; 95 % confidence interval = [ 0.191 , 0.306 ] ) . Conclusion Taken together , these results indicate that a varied training program composed of a number of tasks targeted to different cognitive functions can show transfer to a wide range of untrained measures of cognitive performance . Trial Registration Clinical Trials.gov Two experiments were conducted to compare thec ries of the functional organization of spatial working memory within the human prefrontal cortex . In Experiment I , memory set size for locations was parametrically varied , allowing for the assessment of BOLD signal across maintenance requirements . In the sec ond experiment , manipulation of spatial information held in working memory was contrasted with simple maintenance of that information . Both experiment evoked significant activity in a distributed spatia working memory network . Although dorsolateral prefrontal activation increased monotonically with memory set size , this region was differentially engaged in task conditions involving explicit manipulation of in ternal representations . Activation in the superior frontal sulcal region was associated with maintenance of spatial information , increasing with memory se size . In contrast , ventrolateral prefrontal activation was present only at the highest memory set size , possibly due to the differential use of organizational strategies with more complex stimuli . These results sup port cl aims that the dorsolateral prefrontal cortex is involved in the manipulation of internal representa tions and that the superior frontal sulcal region is involved in the maintenance of spatial information but they suggest a complex role for the ventrolatera prefrontal region Affective cognitive control capacity ( e.g. , the ability to regulate emotions or manipulate emotional material in the service of task goals ) is associated with professional and interpersonal success . Impoverished affective control , by contrast , characterizes many neuropsychiatric disorders . Insights from neuroscience indicate that affective cognitive control relies on the same frontoparietal neural circuitry as working memory ( WM ) tasks , which suggests that systematic WM training , performed in an emotional context , has the potential to augment affective control . Here we show , using behavioral and fMRI measures , that 20 d of training on a novel emotional WM protocol successfully enhanced the efficiency of this frontoparietal dem and network . Critically , compared with placebo training , emotional WM training also accrued transfer benefits to a “ gold st and ard ” measure of affective cognitive control – emotion regulation . These emotion regulation gains were associated with greater activity in the targeted frontoparietal dem and network along with other brain regions implicated in affective control , notably the subgenual anterior cingulate cortex . The results have important implication s for the utility of WM training in clinical , prevention , and occupational setting This article provides a Bayes factor approach to multiway analysis of variance ( ANOVA ) that allows research ers to state grade d evidence for effects or invariances as determined by the data . ANOVA is conceptualized as a hierarchical model where levels are clustered within factors . The development is comprehensive in that it includes Bayes factors for fixed and r and om effects and for within-subjects , between-subjects , and mixed design s. Different model construction and comparison strategies are discussed , and an example is provided . We show how Bayes factors may be computed with BayesFactor package in R and with the JASP statistical package Output:	Importantly , all three groups were similar at pre-training for a variety of individual variables purported to moderate transfer of training to fluid intelligence , including personality traits , motivation to train , and expectations of cognitive improvement from training .
MS2602	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Bleeding is the most serious complication of the use of oral anticoagulation in the prevention and treatment of thromoboembolic complications . We studied the frequency of bleeding complications in out patients treated routinely in anticoagulation clinics . METHODS In a prospect i ve cohort from thirty-four Italian anticoagulation clinics , 2745 consecutive patients were studied from the start of their oral anticoagulation ( warfarin in 64 % , acenocourmarol in the rest ) . The target anticoagulation-intensity was low ( international normalised ratio [ INR ] < or = 2.8 ) in 71 % of the patients and high ( > 2.8 ) in the remainder . We recorded demographic details and the main indication for treatment and , every 3 - 4 months , INR and outcome events . Such events included all complications ( bleeding , thrombosis , other ) , although only bleeding events are reported here , and deaths . We divided bleeding into major and minor categories . FINDINGS 43 % of the patients were women . Nearly three-fifths of the patients were aged 60 - 79 ; 8 % were over 80 . The main indication for treatment was venous thrombolism ( 33 % ) , followed by non-ischaemic heart disease ( 17 % ) . Mean follow-up was 267 days . Over 2011 patient-years of follow-up , 153 bleeding complications occurred ( 7.6 per 100 patient-years ) . 5 were fatal ( all cerebral haemorrhages , 0.25 per 100 patient-years ) , 23 were major ( 1.1 ) , and 125 were minor ( 6.2 ) . The rate of events was similar between sexes , coumarin type , size of enrolling centre , and target INR . The rate was higher in older patients : 10.5 per 100 patient-years in those aged 70 or over , 6.0 in those aged under 70 ( relative risk 1.75 , 95 % Cl 1.29 - 2.39 , p < 0.001 ) . The rate was also higher when the indication was peripheral and /or cerebrovascular disease than venous thromboembolism plus other indications ( 12.5 vs 6.0 per 100 patient-years ) ( 1.80 , 1.2 - 2.7 , p < 0.01 ) , and during the first 90 days of treatment compared with later ( 11.0 vs 6.3 , 1.75 , 1.27 - 2.44 , p < 0.001 ) . A fifth of the bleeding events occurred at low anticoagulation intensity ( INR < 2 , rate 7.7 per 100 patient-years of follow-up ) . The rates were 4.8 , 9.5 , 40.5 , and 200 at INRs 2.0 - 2.9 , 3 - 4.4 , 4.5 - 6.9 , and over 7 , respectively ( relative risks for INR > 4.5 , 7.91 , 5.44 - 11.5 , p < 0.0001 ) . INTERPRETATION We saw fewer bleeding events than those recorded in other observational and experimental studies . Oral anticoagulation has become safer in recent years , especially if monitored in anticoagulation clinics . Caution is required in elderly patients and anticoagulation intensity should be closely monitored to reduce periods of overdosing In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Patients who agree and those who refuse clinical trial entry may differ in attitudes towards decision control and the benefits associated with the trial arms . These differences , if they exist , have implication s for the process of obtaining informed consent and for the generalization of the results of a clinical trial . This paper describes the development and initial application of methods design ed to detect such differences . Developmental work involved creating an inventory of instruments design ed to determine patients ' attitudes towards participating in treatment decision making , permitting r and om selection of treatment , and undertaking the risks and benefits associated with the various treatments in a trial . Initial application involved modifying these instruments in terms of an actual chemotherapeutic trial for colonic adenocarcinoma , seeking responses to these measures from 60 non-eligible colorectal cancer patients , then determining whether those who would agree to trial entry differed systematic ally on these measures from those who indicated that they would refuse such a trial . Twenty-five of the respondents reported that , if faced with the actual decision , they would agree to trial entry : 35 would refuse . Refusers dem and ed more participation in decision making ( Chi-square ; P = 0.01 ) and a greater increment in treatment benefit ( t-test ; P = 0.0001 ) . Twenty-two of the 35 refusers reported aversion to r and omization as their primary reason for trial refusal . Since their particular content can be modified , these measures may be applicable to all clinical trials . They could be used to study the reasons patients accept or refuse trial entry and to determine if agreer-refuser attitude differences undermine the generalizability of a trials results CONTEXT Decision aids are tools design ed to help patients participate in the clinical decision-making process . OBJECTIVE To determine whether use of an audiobooklet ( AB ) decision aid explaining the results of a clinical trial affected the decision-making process of study participants . DESIGN R and omized controlled trial conducted from May 1997 to April 1998 . SETTING Fourteen centers that participated in the Stroke Prevention in Atrial Fibrillation ( SPAF ) III trial . PARTICIPANTS A total of 287 patients from the SPAF III aspirin cohort study , in which patients with atrial fibrillation and a relatively low risk of stroke received 325 mg/d of aspirin and were followed up for a mean of 2 years . INTERVENTION At the end of SPAF III , participants were r and omized to be informed of the study results with usual care plus use of an AB ( AB group ) vs usual care alone ( control group ) . The AB included pertinent information to help patients decide whether to continue taking aspirin or switch to warfarin . MAIN OUTCOME MEASURES Patients ' ability to make choices regarding antithrombotic therapy , and 6-month adherence to these decisions . Their knowledge , expectations , decisional conflict ( the amount of uncertainty about the course of action to take ) , and satisfaction with the decision-making process were also measured . RESULTS More patients in the AB group made a choice about antithrombotic therapy than in the control group ( 99 % vs 94 % ; P = .02 ) . Patients in the AB group were more knowledgeable and had more realistic expectations about the risk of stroke and hemorrhage ( in the AB group , 53%-80 % correctly estimated different risks ; in the control group , 16%-28 % gave correct estimates ) . Decisional conflict and satisfaction were similar for the 2 groups . After 6 months , a similar percentage of patients were still taking their initial choice of antithrombotic therapy ( 95 % vs 93 % ; P = .44 ) . CONCLUSIONS For patients with atrial fibrillation who had participated in a major clinical trial , the use of an AB decision aid improved their underst and ing of the benefits and risks associated with different treatment options and helped them make definitive choices about which therapy to take . Further studies are necessary to evaluate the acceptability and impact of decision aids in other clinical setting In early 1983 , all 1,280 faculty and resident physicians at one hospital who were eligible to be vaccinated against hepatitis B were divided r and omly into three groups : Group 1 physicians received general information about the risks and benefits of alternative vaccine decisions ; Group 2 physicians were additionally invited to provide personal information for an individualized decision analysis ( 12.6 percent responded ) ; and Group 3 physicians , who served as controls , were not contacted . In one year 's follow-up , 20 percent of physicians were screened for hepatitis B antibody or vaccinated . More Group 2 physicians whose decision analyses recommended screening or vaccination took these actions ( 39 percent ) than any other group . Group assignment remained significantly associated with vaccine decisions after analyzing results by the " intention to treat " principle , and after adjusting for training status , exposure to blood and blood products , and pre- study intentions about the vaccine . Despite the low overall vaccine acceptance rate , it is concluded that individualized decision analysis can influence the clinical decisions taken by knowledgeable and interested patients BACKGROUND Given the greater uncertainty surrounding probability estimates associated with qualitative ( use of words or phrases ) descriptions , the use of quantitative ( numerical ) information to communicate the risks and benefits of therapies is recommended but the impact of its use in decision aids is unexplored . OBJECTIVE Using stroke prevention in atrial fibrillation as an example , to compare the impact of quantitative vs. qualitative descriptions of probability risk estimates in decision aids on the clinical decision-making process . DESIGN R and omized trial with a 2 x 2 factorial design . SUBJECTS A total of 198 volunteers aged 60 - 80 years . SETTING Outpatient clinics of a university-affiliated , tertiary-care teaching hospital . METHODS Participants were asked to imagine that they had atrial fibrillation , and using a decision aid , were then r and omized to two ways of receiving pertinent risk information regarding the probability of stroke and major bleeding when taking warfarin , aspirin or no therapy : ( 1 ) quantitatively , in which the 2-year probabilities of stroke and major haemorrhage were presented both numerically and graphically with 100 faces ( e.g. 8 of 100 ) , and ( 2 ) qualitatively in which these probabilities were presented with the use of verbal phrases ( e.g. very low , moderate ) . OUTCOME MEASURES Primary : decisional conflict . Secondary : participants ' choices , knowledge and expectations of outcomes using qualitative and quantitative scales . RESULTS Participants review ing quantitative risk information scored better on the informed subscale of the decisional conflict scale ( P < 0.05 ) and , as expected , were better able to estimate numerically their chance of stroke and bleeding when taking warfarin , aspirin or no medication . For the low risk arm , there were no significant differences in treatment choices for the qualitative and quantitative groups . For the moderate risk arm , treatment choices between the two groups were significantly different ( P = 0.01 ) , with those in the quantitative group more likely to make an actual choice and to choose therapies at the extremes of effectiveness ( warfarin and no treatment ) . There were no significant differences between the quantitative and qualitative groups in their ability to rank-order their stroke risk when taking warfarin , aspirin and no treatment , overall knowledge about atrial fibrillation and its treatment , and other dimensions of decisional conflict ( all P-values > 0.05 ) . CONCLUSIONS For participants without the disease in question , this study found that providing sufficient quantitative risk information makes them feel more informed , which sometimes affects their treatment choices . Further studies are necessary to confirm these findings for patients making actual clinical decisions The management of carotid artery stenosis is an art evolving into a science , increasingly informed by clinical trials of medical management versus carotid endarterectomy ( CEA ) . Ideas about optimal management depend on the confluence of patient-specific variables , surgical expertise , and the state of medical knowledge . In this complex and progressing setting , an up-to- date decision support system could help physicians apply the latest evidence to patient care . Carotid ultrasonography ( US ) studies provide an excellent opportunity to aid in the therapy of carotid stenosis . We developed a Carotid US Report Enhancement ( CURE ) to augment carotid US reports with treatment-specific prognostic information and patient-specific portions of the American Heart Association 's 1998 guideline for the management of carotid artery stenosis . In the process of design ing and implementing the CURE software , we encountered and eventually solved a variety of problems . The first problem was that US test was not always precise enough to distinguish between a moderate and mild carotid stenosis . Likewise , the st and ard US reports did not eluci date several technical problems that decreased the reliability of the US result . Third , although 17 of 18 physicians agreed to receive the CURE reports , they requested non-incriminating wording . Fourth , vascular surgeons supervising the US laboratories were reluctant to support the CURE report if they thought it would be construed as prompting self-referral . Finally , information about some comorbid conditions ( e.g. a history of atrial fibrillation ) could not be obtained reliably from the patients . The result of responding to these problems is a decision support program that is increasingly robust , able to detect many of its own limitations , and capable of integrating data from multiple sources . A r and omized controlled trial now in progress will evaluate the clinical impact of the CURE program The Canadian Atrial Fibrillation Anticoagulation Study was a r and omized double-blind placebo-controlled trial to assess the potential of warfarin to reduce systemic thromboembolism and its inherent risk of hemorrhage . As Output:	For patients with atrial fibrillation , treatment recommendations from clinical practice guidelines often differ from patient preferences , with substantial heterogeneity in their individual preferences .
MS2603	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A grade five through eight substance abuse prevention program , later incorporated into the Michigan Model for Comprehensive School Health Education , was developed , implemented , and evaluated . Results focus on students who received seven lessons on alcohol in grade six , and eight lessons on tobacco , alcohol , marijuana , and cocaine in grade seven taught by their regular classroom teachers ( after a 6-hour training in the social pressures resistance skills curriculum ) . Students ( N = 442 ) received either two years of the program or none , and completed individually-coded question naires . Repeated measures analysis of variance result ed in significant treatment by occasion interactions on the use of alcohol , cigarettes , marijuana , cocaine , and other drugs , as well as on knowledge . At the end of grade seven , program students ' rates of substance use had increased significantly less and knowledge of alcohol pressures , effects , and skills to resist had increased significantly more than those of comparison students OBJECTIVES This paper presents the 1-year outcomes evaluation of Project Towards No Drug Abuse ( Project TND ) , a large-scale indicated drug abuse prevention program in southern California applied to continuation high school youth , who are at high risk for drug abuse . METHODS The efficacy of nine-lesson health motivation -- social skills -- decision-making curriculum was evaluated in a three-condition experimental design . Twenty-one schools were r and omly assigned by block to one of three conditions -- st and ard care ( control ) , classroom program , and classroom program plus a semester-long school-as-community component . A pretest was followed by a 3-week-long drug abuse prevention program and then a posttest at 14 continuation high schools . The 7 st and ard care schools received only the pretest followed by the posttest ( same time duration ) . Subjects were followed up 1 year later . RESULTS Changes in use of cigarettes , alcohol , marijuana , and hard drugs were assessed in a pretest-1-year follow-up time interval . The follow-up rate was 67 % ( analysis n = 1,074 ) . Indicated preventive effects were found on alcohol and hard drug use . No differences were found across the two program conditions . CONCLUSIONS Project TND is the first program to demonstrate 1-year self-reported behavioral effects on alcohol use and hard drug use among older , high-risk youth by using a school-based , limited-session model This paper presents the findings from a controlled prospect i ve study of the effectiveness of a school-based alcohol education package for 13 year olds . The research had three phases : ( 1 ) baseline survey of alcohol-related knowledge , attitudes and behaviour ; ( 2 ) development and teaching of a short alcohol education package and ( 3 ) follow-up survey . The results indicate that the students who received the alcohol education knew more about alcohol than the controls . In addition , the educational intervention was found to have influenced the self-reported last consumption of alcohol and maximum consumption , with the ' educated ' youngsters generally exhibiting more restrained behaviour . There has been little scientific evidence that past alcohol education has been effective in changing young people 's drinking behaviour . The outcome of this research reinforces some recent studies which suggest the way forward may lie in an educational approach which takes account of social influences on substance use and misuse The entire early adolescent population of the 15 communities that constitute the Kansas City ( Kansas and Missouri ) metropolitan area has participated in a community-based program for prevention of drug abuse since September 1984 . The Kansas City area is the first of two major metropolitan sites being evaluated in the Midwestern Prevention Project , a longitudinal trial for primary prevention of cigarette , alcohol , and marijuana use in adolescents . The project includes mass media programming , a school-based educational program for youths , parent education and organization , community organization , and health policy components that are introduced sequentially into communities during a 6-year period . Effects of the program are determined through annual assessment s of adolescent drug use in schools that are assigned to immediate intervention or delayed intervention control conditions . In the first 2 years of the project , 22,500 sixth- and seventh- grade adolescents received the school-based educational program component , with parental involvement in homework and mass media coverage . Analyses of 42 schools indicate that the prevalence rates of use for all three drugs are significantly lower at 1-year follow-up in the intervention condition relative to the delayed intervention condition , with or without controlling for race , grade , socioeconomic status , and urbanicity ( 17 % vs 24 % for cigarette smoking , 11 % vs 16 % for alcohol use , and 7 % vs 10 % for marijuana use in the last month ) , and the net increase in drug use prevalence among intervention schools is half that of delayed intervention schools OBJECTIVE To examine the effectiveness of a brief , school-based intervention for preventing alcohol use . DESIGN AND SETTING R and omized , control trial assigning inner-city public school students to an intervention program or a comparison program . PARTICIPANTS Sixth , seventh , and eighth grade students in Jacksonville , Fla ( N=104 ) . INTERVENTIONS Students assigned to the intervention program were given a self-instructional module and corresponding audiotape , a health consultation with a physician or nurse , and a follow-up consultation with a trained peer health model . MAIN OUTCOME MEASURES Alcohol consumption during the month after the intervention and students ' assessment s of the interventions were measured . RESULTS Students ' t tests showed participants were more satisfied with physician or nurse consultations than with peer consultations or the self-instructional module and audiotapes ( P=.05 ) . Analysis of covariance tests showed significant main effects for 30-day quantity of alcohol use ( F=5.15 , P=.02 ) , with intervention students reporting less alcohol consumption at follow-up than comparison students , and for 30-day frequency of alcohol use ( F=5.92,P=.01 ) with intervention students again showing less frequent use at follow-up . CONCLUSIONS A multicomponent , school-based intervention using print and audiotape media , brief physician or nurse consultations , and follow-up peer contacts holds promise in altering short-term alcohol use and selected behavioral factors among inner-city youth This study evaluated the substance initiation effects of an intervention combining family and school-based competency-training intervention components . Thirty-six rural schools were r and omly assigned to 1 of 3 conditions : ( a ) the classroom-based Life Skills Training ( LST ) and the Strengthening Families Program : For Parents and Children 10 - 14 , ( b ) LST only , or ( c ) a control condition . Outcomes were examined 1 year after the intervention posttest , using a substance initiation index ( SII ) measuring lifetime use of alcohol , cigarettes , and marijuana and by rates of each individual substance . Planned intervention-control contrasts showed significant effects for both the combined and LST-only interventions on the SII and on marijuana initiation . Relative reduction rates for alcohol initiation were 30.0 % for the combined intervention and 4.1 % for LST only An alcohol misuse prevention curriculum for tenth- grade students was developed , implemented , and evaluated through twelfth grade with 1041 students from four school districts . The curriculum emphasized social pressures resistance training , immediate effects of alcohol , risks of alcohol misuse , and social pressures to misuse alcohol . There were desirable program effects on alcohol misuse prevention knowledge ( p < 0.001 ) , alcohol misuse ( p < 0.02 ) , and refusal skills ( p < 0.09 ) . Gender by occasion differences were found on alcohol use , alcohol misuse , and driving after drinking , with boys ' rates increasing more than those of girls . Exposure to a sixth- grade , as well as the tenth- grade , program did not result in better outcomes . Despite high levels of alcohol use among high school students , a tenth- grade curriculum can result in some desirable effects . Creative approaches are needed , however , especially for boys who tend to use and misuse alcohol at rates that increase more steeply than those of girls Alcohol-related injuries are a leading cause of death in mid and late adolescence . Schools might contribute to the prevention of these injuries by affecting adolescent drinking . Few school programmes , however , have succeeded . In view of this shortcoming , a previously investigated school based health counselling programme for mid adolescents was applied to work in conjunction with a municipal alcohol policy initiative . A pre-test/post-test quasi-experimental study of 118 sixteen year old students was carried out . The development of alcohol consumption was not found to differ significantly between the experimental and control groups . The students ' perceptions of the negative effects of use of alcohol did not increase . The lack of effect of the counselling programme might be related to the low significance initially attributed by the students to alcohol as a health issue . A shift of emphasis in the schools , from normative education , to discussion s of the immediate threats of serious injuries might alter this perception This r and omized controlled trial evaluated the efficacy of a brief intervention design ed to reduce the harmful consequences of heavy drinking among high-risk college students . Students screened for risk while in their senior year of high school ( 188 women and 160 men ) were r and omly assigned to receive an individualized motivational brief intervention in their freshman year of college or to a no-treatment control condition . A normative group selected from the entire screening pool provided a natural history comparison . Follow-up assessment s over a 2-year period showed significant reductions in both drinking rates and harmful consequences , favoring students receiving the intervention . Although high-risk students continued to experience more alcohol problems than the natural history comparison group over the 2-year period , most showed a decline in problems over time , suggesting a developmental maturational effect OBJECTIVE To evaluate the long-term efficacy of a school-based approach to drug abuse prevention . DESIGN R and omized trial involving 56 public schools that received the prevention program with annual provider training workshops and ongoing consultation , the prevention program with videotaped training and no consultation , or " treatment as usual " ( ie , controls ) . Follow-up data were collected 6 years after baseline using school , telephone , and mailed surveys . PARTICIPANTS A total of 3597 predominantly white , 12th- grade students who represented 60.41 % of the initial seventh- grade sample . INTERVENTION Consisted of 15 classes in seventh grade , 10 booster sessions in eighth grade , and five booster sessions in ninth grade , and taught general " life skills " and skills for resisting social influences to use drugs . MEASURES Six tobacco , alcohol , and marijuana use self-report scales were recorded to create nine dichotomous drug use outcome variables and eight polydrug use variables . RESULTS Significant reductions in both drug and polydrug use were found for the two groups that received the prevention program relative to controls . The strongest effects were produced for individuals who received a reasonably complete version of the intervention -- there were up to 44 % fewer drug users and 66 % fewer polydrug ( tobacco , alcohol , and marijuana ) users . CONCLUSIONS Drug abuse prevention programs conducted during junior high school can produce meaningful and durable reductions in tobacco , alcohol , and marijuana use if they ( 1 ) teach a combination of social resistance skills and general life skills , ( 2 ) are properly implemented , and ( 3 ) include at least 2 years of booster sessions This study developed and tested skills- and community-based approaches to prevent substance abuse among Native American youth . After completing pretest measurements , 1,396 third- through fifth- grade Native American students from 27 elementary schools in five states were divided r and omly by school into two intervention arms and one control arm . Following intervention delivery , youths in all arms completed posttest measurements and three annual follow-up measurements . Youths in schools assigned to the intervention arms learned cognitive and behavioral skills for substance abuse prevention . One intervention arm additionally engaged local community residents in efforts to prevent substance use among Native American youth . Outcome assessment batteries measured youths ' reported use of smoked and smokeless tobacco , alcohol , and marijuana . Over the course of the 3.5-year study , increased rates of tobacco , alcohol , and marijuana use were reported by youths across the three arms of the study . Though cigarette use was unaffected by intervention , follow up rates of smokeless tobacco , alcohol , and marijuana use were lower for youths who received skills intervention than for youths in the control arm . Community intervention components appeared to exert no added beneficial influence on youths ' substance use , beyond the impact of skills intervention components alone . Finally , gender differences were apparent across substances , measurements , and study arms , with girls smoking more cigarettes and boys using more smokeless tobacco , alcohol , and marijuana This study assessed the impact of school-based social competence training on skills , social adjustment , and self-reported substance use of 282 sixth and seventh grade rs . Training emphasized broad-based competence promotion in conjunction with domain-specific application to substance abuse prevention . The 20-session program comprised six units : stress management , self-esteem , problem solving , substances and health information , assertiveness , and social networks . Findings indicated positive training effects on Ss ' skills in h and ling interpersonal problems and coping with anxiety . Teacher ratings revealed improvements in Ss ' constructive conflict resolution with peers , impulse control , and popularity . Self-report ratings indicated gains in problem-solving efficacy . Results suggest some preventive impact on self-reported substance use intentions and excessive alcohol use . In general , the program was found to be beneficial for both inner-city and suburban students OBJECTIVE Systematic evaluation of theoretically and empirically based family programs to prevent adolescent alcohol use/misuse is limited . Data presented here are from a longitudinal study evaluating a home-based universal adolescent alcohol use prevention program . The intervention was design ed to enhance protective factors and minimize risk factors identified as influencing adolescent alcohol use . METHOD A r and omized pretest/posttest repeated measures design was used . Adolescents ( N = 428 ; 54 % females , Output:	No firm conclusions about the effectiveness of prevention interventions in the short- and medium term were possible . Over the longer term ( > 3 years ) , the Strengthening Families Programme ( SFP ) showed promise as an effective prevention intervention .
MS2604	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background and Purpose : The purpose of this sequential intervention study was to determine the rate of local recurrences and the rate of distant metastases in patients with invasive breast cancer who had been treated with breast-conserving surgery and postoperative radiation therapy to the whole breast either with postoperative electron boost in group 1 or with intraoperative electron boost ( IORT ) in group 2 . Patients and Methods : After breast-conserving surgery , 378 women with invasive breast cancer of tumor sizes T1 and T2 received 51–56.1 Gy of postoperative radiation therapy to the whole breast in 1.7-Gy fractions . 188 of those patients additionally received a postoperative electron boost of 12 Gy in group 1 from January 1996 to October 1998 . Consecutively , from October 1998 to March 2001 , 190 patients received intraoperative electron-boost radiotherapy of 9 Gy to the tumor bed in group 2 . The groups were comparable with regard to age , menopausal status , tumor size , grading , and nodal status . All statistical tests were twosided . Results : During a median follow-up period of 55.3 months in group 1 and 25.8 months in group 2 , local recurrences were observed in eight of 188 patients ( 4.3 % ) in group 1 , and no local recurrence was seen in group 2 ( p = 0.082 ) . Distant metastases occurred in 15 of the 188 patients ( 7.9 % ) in group 1 and in two of the 190 patients ( 1.1 % ) in group 2 ( p = 0.09 ) . The 4-year actuarial rates of local recurrence were 4.3 % ( 95 % confidence interval , 1.8–8.2 % ) and 0.0 % ( 95 % confidence interval , 0.0–1.9 % ) and the 4-year actuarial rates of distant metastases were 7.9 % ( 95 % confidence interval , 4.5–12.8 % ) and 1.1 % ( 95 % confidence interval , 0.1–3.8 % ) . Conclusion : Immediate IORT boost yielded excellent local control figures in this prospect i ve investigation and appears to be superior to conventional postoperative boost in a short-term follow-up . Hintergrund und Ziel : Ziel dieser sequentiellen Interventions studie war die Bestimmung der Lokalrezidiv- und Fernmetastasenrate von Patientinnen mit invasivem Mammakarzinom , die mit brusterhaltender Operation und anschließender Bestrahlung der gesamten Brust , aber verschiedenen Boostbestrahlungen therapiert worden waren . Gruppe 1 erhielt eine postoperative Boostbestrahlung und Gruppe 2 eine intraoperative Radiotherapie ( IORT ) in Boostmodalität . Patienten und Method ik : Nach brusterhaltender Operation erhielten 378 Patientinnen mit invasivem Mammakarzinom mit T1- und T2-Tumoren eine postoperative Bestrahlung der gesamten Brust von 51–56.1 Gy in 1.7-Gy-Fraktionen . Von Januar 1996 bis Oktober 1998 bekamen 188 Patientinnen in Gruppe 1 postoperativ zusätzlich eine Elektronenboostbestrahlung von 12 Gy . Von Oktober 1998 bis März 2001 erhielten 190 Patientinnen in Gruppe 2 eine intraoperative Elektronenboostbestrahlung von 9 Gy direkt auf das Tumorbett . Beide Gruppen waren bezüglich Alter , Menopausenstatus , Tumorgröße , Grading und Nodalstatus vergleichbar . Die statistische Analyse erfolgte zweiseitig . Ergebnisse : Nach einer mittleren Nachbeobachtungszeit von 55,3 Monaten in Gruppe 1 und 25,8 Monaten in Gruppe 2 traten bei acht der 188 Patientinnen in Gruppe 1 ( 4,3 % ) Lokalrezidive auf , während es in Gruppe 2 zu keinem Lokalrezidiv kam ( p = 0.082 ) . Fernmetastasen ereigneten sich bei 15 der 188 Patientinnen ( 7,9 % ) in Gruppe 1 und zwei der 190 Patientinnen ( 1,1 % ) in Gruppe 2 ( p = 0.09 ) . Die 4-Jahres-Raten für Lokalrezidive betrugen 4,3 % ( 95%-Konfidenzintervall 1,8–8,2 % ) und 0 % ( 95%- Konfidenzintervall 0–1,9 % ) und die 4-Jahres-Raten für Fernmetastasen 7,9 % ( 95%-Konfidenzintervall 4.5–12,8 % ) und 1,1 % ( 95%-Konfidenzintervall 0,1–3,8%).Schlussfolgerung : Die intraoperative Boostbestrahlung zeigt exzellente Ergebnisse bezüglich der Lokalrezidivrate und scheint der postoperativen Boostbestrahlung in der Kurzzeitnachbeobachtung überlegen zu sein The aim of this trial was to study the value of adding post-operative radiotherapy to lumpectomy in a subgroup of breast cancer patients with favourable patient- , tumour- , and treatment-related prognostic features . 152 women aged over 40 with unifocal breast cancer seen in preoperative mammography were r and omly assigned to lumpectomy alone ( no-XRT group ) or to lumpectomy followed by radiotherapy to the ipsilateral breast ( 50 Gy given within 5 weeks , XRT group ) . All cancers were required to be invasive node-negative , smaller than 2 cm in diameter and well or moderately differentiated , to contain no extensive intraductal component , to be progesterone receptor-positive , DNA diploid , have S-phase fraction ≤7 and be excised with at least 1 cm margin . During a mean follow-up time of 6.7 years , 13 ( 18.1 % ) cancers recurred locally in the no-XRT and 6 ( 7.5 % ) in the XRT group ( P=0.03 ) . There was no difference between the groups in the ultimate breast preservation rate ( 95.0 % vs. 94.4 % in XRT and no-XRT , respectively , P=0.88 ) , distant metastasis-free survival ( P=0.36 ) , or 5-year cancer-specific survival ( 97.1 % in XRT and 98.6 in no-XRT ) . Radiation therapy given after lumpectomy reduces the frequency of ipsilateral breast recurrences even in women with small breast cancer with several favourable clinical and biological features . However , the breast preservation rate may not increase due to more frequent use of salvage mastectomies in patients treated with postoperative radiotherapy . © 2001 Cancer Research Campaign PURPOSE To evaluate perioperative morbidity , toxicity , and cosmetic outcome in patients treated with interstitial brachytherapy to the tumor bed as the sole irradiation modality after breast-conserving surgery . PATIENTS AND METHODS From November 1 , 2000 to January 31 , 2004 , 176 women with early-stage breast cancer became partakers in a protocol of tumor bed irradiation alone using pulsed-dose-rate ( PDR ) or high-dose-rate ( HDR ) interstitial multicatheter implants . Patients became eligible , if their tumor was an infiltrating carcinoma < or = 3 cm in diameter , the surgical margins were clear by at least 2 mm , the axilla was surgically staged node-negative , the tumor was estrogen and /or progesterone receptor-positive , well or moderately differentiated ( G1/2 ) , the tumor did not contain an extensive intraductal component ( EIC ) and the patient 's age was > 35 years . Implants were positioned using a template guide , delivering either 49.8 Gy in 83 consecutive hours ( PDR ) or 32.0 Gy in two daily fractions over 4 days ( HDR ) . Perioperative morbidity , toxicity , and cosmetic outcome were assessed . Interim findings of the first 69 patients , who were treated in this multicenter trial , after a median follow-up of 24 months ( range , 15 - 39 months ) are presented . RESULTS One of the 69 patients ( 1.4 % ) developed a bacterial infection of the implant . No other perioperative complications , for example bleeding or hematoma , were observed . Acute toxicity was low : 2.9 % of the patients ( 2/69 ) experienced mild radiodermatitis . Late toxicity : hypersensation/mild pain 7.2 % ( 5/69 ) , intermittent but tolerable pain 1.4 % ( 1/69 ) , mild dyspigmentation 10.1 % ( 7/69 ) , mild fibrosis 11.6 % ( 8/69 ) , moderate fibrosis 1.4 % ( 1/69 ) , mild telangiectasia ( < 1 cm(2 ) ) 11.6 % ( 8/69 ) , and moderate teleangiectasia ( 1 - 4 cm(2 ) ) 1.4 % ( 1/69 ) . Good to excellent cosmetic results were observed in 92.4 % of the patients evaluated . All patients ( n = 176 ) remained disease-free to the date of evaluation . CONCLUSION This analysis indicates that accelerated partial breast irradiation with iridium-192 interstitial multicatheter PDR/HDR implants is feasible with low perioperative morbidity , low acute and mild late toxicity , and does not significantly affect cosmetic results at a median follow-up of 24 months AIM We believe that conservative treatment of early breast cancer may not require radiotherapy that encompasses the whole breast in all patients . We have developed a novel therapeutic approach that allows targeted intraoperative radiotherapy ( Targit ) to be safely and accurately delivered in a st and ard operating theatre . We are currently recruiting for a r and omized trial testing whether Targit can replace the whole 6 weeks of post-operative radiotherapy after breast conserving surgery . METHODS This paper describes the operative technique . It employs a miniature electron-beam-driven X-ray source called INTRABEAM ( PeC ) that emits soft X-rays ( 50 kV ) from within the breast . The X-rays are emitted from the tip of a 10 cm x 3.2 mm diameter probe , that is enclosed in a spherical applicator ( available in 2.5 - 5 cm diameter sizes ) , which in turn is inserted in the tumour bed and intraoperative radiotherapy is delivered in about 25 min . The prescribed dose is 5 and 20 Gy at 1 cm and 0.2 cm respectively , from the tumour bed . RESULTS The biologically effective dose is 7 - 53 Gy for alpha/beta=10 and 20 - 120 Gy for alpha/beta=1.5 . The quick attenuation of the radiation reduces the damage to normal tissues and allows radiotherapy to be delivered in a st and ard operating theatre . Tungsten impregnated rubber sheets , cut to size , are placed on the chest wall to protect the heart/lungs and over the wound to stop stray radiation . The skin dose is monitored with thermoluminescent detectors ( TLDs ) . After wide local excision of the tumour and good haemostasis , a spherical applicator is inserted in the tumour bed and the target breast tissues are wrapped around it with a purse-string suture . Thus , true conformation of the target around the applicator source is achieved in real time . CONCLUSION As a tumour bed boost , this technique has the potential to reduce local recurrence by avoiding geographical misses and achieving excellent dosimetry . In patients with low risk of local recurrence , it has the potential to replace the full 6 weeks of post-operative radiotherapy with considerable implication s to patients and hospitals BACKGROUND In women 70 years of age or older who have early breast cancer , it is unclear whether lumpectomy plus tamoxifen is as effective as lumpectomy followed by tamoxifen plus radiation therapy . METHODS Between July 1994 and February 1999 , we r and omly assigned 636 women who were 70 years of age or older and who had clinical stage I ( T1N0M0 according to the tumor-node-metastasis classification ) , estrogen-receptor-positive breast carcinoma treated by lumpectomy to receive tamoxifen plus radiation therapy ( 317 women ) or tamoxifen alone ( 319 women ) . Primary end points were the time to local or regional recurrence , the frequency of mastectomy for recurrence , breast-cancer-specific survival , the time to distant metastasis , and overall survival . RESULTS The only significant difference between the two groups was in the rate of local or regional recurrence at five years ( 1 percent in the group given tamoxifen plus irradiation and 4 percent in the group given tamoxifen alone , P<0.001 ) . There were no significant differences between the two groups with regard to the rates of mastectomy for local recurrence , distant metastases , or five-year rates of overall survival ( 87 percent in the group given tamoxifen plus irradiation and 86 percent in the tamoxifen group , P=0.94 ) . Assessment by physicians and patients of cosmetic results and adverse events uniformly rated tamoxifen plus irradiation inferior to tamoxifen alone . CONCLUSIONS Lumpectomy plus adjuvant therapy with tamoxifen alone is a realistic choice for the treatment of women 70 years of age or older who have early , estrogen- Output:	Conclusion : Despite controversies regarding PBI after breast-conserving surgery , results of phase I – II trials suggest that sole tumor bed irradiation might be an appropriate therapeutic alternative for selected breast cancer patients .
MS2605	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Subcortical vascular dementia ( VaD ) is characterized by executive dysfunction and behavioral problems , reflecting deterioration of the frontal lobe . This study aim ed to determine whether rivastigmine , a dual inhibitor of acetylcholinesterase ( AChE ) and butyrylcholinesterase ( BuChE ) , has any effects on the typical symptoms of subcortical VaD. Patients receiving rivastigmine showed a slight improvement in executive functions and in behavior . Side effects in both groups were tolerable and there were no study withdrawals . Moreover , there are no drug interactions with other therapies previously and concomitantly assumed . Improvements in domains that characterize subcortical VaD were observed , indicating that rivastigmine may have provided targeted treatment in areas of the brain that are particularly affected in this patient population BACKGROUND The majority of patients with Alzheimer 's disease ( AD ) or vascular dementia display , in addition to cognitive impairment , various degrees of behavioral disturbances . As the use of cholinesterase inhibitors for the treatment of cognitive impairment in dementia becomes widespread , many of these patients will be treated concomitantly with cholinesterase inhibitors and with anti-psychotic drugs to ameliorate behavioral disturbances . Despite the widespread use of this combination in clinical practice , the safety and tolerability of such combination therapy has not been evaluated in controlled clinical trials . This pilot study examined the effects of addition of risperidone 0.5 - 2 mg/day to patients on rivastigmine 3 - 12 mg/day , and vice versa . METHODS 65 patients suffering from AD , 10 from vascular dementia , and 15 from both were r and omized to open label rivastigmine and risperidone , alone or in combination , for 20 weeks . Adverse events caused by co-administration were assessed . RESULTS No clinical ly relevant adverse interactions were observed . CONCLUSIONS These preliminary results indicate that rivastigmine and risperidone can be safely co-administered . Confirmation of these results in large clinical trials studies is warranted Further to recent data indicating that patients with vascular dementia ( VaD ) show a cholinergic deficit , we aim ed to determine whether rivastigmine , a dual inhibitor of acetylcholinesterase ( AChE ) and butyrylcholinesterase ( BuChE ) , has any effects on the symptoms of VaD. Patients aged 65 - 80 , with a diagnosis of dementia and probable VaD , received rivastigmine 3 - 6 mg/day ( n=8 ) or cardioaspirin ( n=8 ) in an open study for 22 months . At 22 months , patients treated with rivastigmine showed significant improvements in executive function and behavioural symptoms ( both p<0.05 vs. both baseline and control group ) , which were reflected in reduced caregiver stress ( p<0.05 vs. baseline and controls ) . Baseline scores of global response , cognition , word fluency and activities of daily living were maintained in patients receiving rivastigmine , and there was no increase in benzodiazepine or neuroleptic intake . In contrast , the control group showed no improvements in any domain , and significant deterioration in global response and executive function ( both p<0.05 vs. baseline and rivastigmine group ) . Side effects in both groups were tolerable and there were no study withdrawals . Long-term rivastigmine treatment appeared to be safe and effective in this patient population . In particular , improvements in domains particularly relevant to this condition were observed . These benefits may reflect the drug 's dual inhibitory effects on the cholinergic system , and its particular activity in frontal areas of the brain . A large , double-blind study of rivastigmine in patients with VaD would be worthwhile A number of studies have suggested that cerebral changes , particularly deep white matter lesions ( WML ) visualized on magnetic resonance imaging ( MRI ) , may be involved in the genesis of late life depression . This has been confirmed in a prospect i ve study which also found a relationship between the presence of WML and poor 3-year outcome in elderly depressed subjects . Most studies find these lesions to predominate in frontal lobe and basal ganglia , supporting the hypothesis of " fronto-striatal " dysfunction in depression . To investigate whether WML are associated with mood disturbance in dementia , proton density and T2-weighted images were obtained in 80 subjects with dementia ( dementia with Lewy bodies , n = 27 ; Alzheimer 's disease , n = 28 ; vascular dementia , n = 25 ) and 26 age-matched normal controls . Periventricular lesions ( PVL ) , white matter lesions ( WML ) , and basal ganglia hyperintensities ( BG ) were visually rated blind to diagnosis using a semiquantitative scale . Frontal WML were associated with higher depression scores in patients with dementia , implying a common pathophysiology of depression irrespective of diagnosis . Further study of the neurobiological basis of WML is needed . This can best be achieved by serial clinical assessment combined with in vivo and in vitro MRI and neuropathological examination BACKGROUND Vascular risk factors play a role in the development of dementia , including Alzheimer disease ( AD ) . However , little is known about the effect of body mass index and clustering of vascular risk factors on the development of dementia . OBJECTIVE To investigate the relation between midlife body mass index and clustering of vascular risk factors and subsequent dementia and AD . DESIGN AND SETTING Participants of the Cardiovascular Risk Factors , Aging , and Dementia ( CAIDE ) study were derived from r and om , population -based sample s previously studied in a survey carried out in 1972 , 1977 , 1982 , or 1987 . After an average follow-up of 21 years , 1449 individuals ( 73 % ) aged 65 to 79 years participated in the reexamination in 1998 . MAIN OUTCOME MEASURES Dementia and AD . RESULTS Obesity at midlife ( body mass index>30 kg/m2 ) was associated with the risk of dementia and AD even after adjusting for sociodemographic variables ( odds ratio [ OR ] , 2.4 [ 95 % confidence interval ( CI ) , 1.2 - 5.1 ] ) . The association was somewhat modified by further adjusting for midlife blood pressure , total cholesterol level , and smoking ( OR , 2.1 [ 95 % CI , 1.0 - 4.6 ] ) and also for apolipoprotein E genotype and history of vascular disorders ( OR , 1.9 [ 95 % CI , 0.8 - 4.6 ] ) . Midlife obesity , high total cholesterol level , and high systolic blood pressure were all significant risk factors for dementia with ORs of around 2 for each factor , and they increased the risk additively ( OR , 6.2 for the combination ) . CONCLUSIONS Obesity at midlife is associated with an increased risk of dementia and AD later in life . Clustering of vascular risk factors increases the risk in an additive manner . The role of weight reduction for the prevention of dementia needs to be further investigated We evaluated the efficacy and safety of the central ly acting cholinesterase inhibitor , rivastigmine tartrate , for patients with mild to moderately severe Alzheimer 's disease ( AD ) with or without concurrent vascular risk factors ( VRF ) . Patients ( 45 - 90 years of age ) were r and omized to placebo ( n = 235 ) , low-dose rivastigmine ( 1 - 4 mg/day , n = 233 ) , or high-dose rivastigmine ( 6 - 12 mg/day , n = 231 ) for 26 weeks . Efficacy measures included the Alzheimer 's Disease Assessment Scale-Cognitive subscale ( ADAS-Cog ) , the Clinician 's Interview Based Impression of Change ( CIBIC-Plus ) , the Progressive Deterioration Scale ( PDS ) , the Global Deterioration Scale ( GDS ) , and the Mini-Mental State Examination ( MMSE ) . For efficacy and safety analysis , patients were categorized by baseline Modified Hachinski Ischemic Score ( MHIS ) for the determination of VRF ( MHIS > 0 : presence of VRF ; MHIS = 0 : absence of VRF ) . As early as 12 weeks , the mean change from the baseline ADAS-Cog score was significantly different for those patients treated with high-dose rivastigmine compared with placebo controls in both MHIS categories . However , the treatment difference between high-dose rivastigmine and placebo at each time-point was larger for patients with MHIS > 0 . The proportion of responders was significantly greater in the high-dose rivastigmine group for each level of improvement . No differences were noted between treatment groups regarding safety evaluations . Rivastigmine is effective in both categories of patients , and those with VRF experience greater clinical benefit ( cognition , activities of daily living , and disease severity ) Narasimhalu K , Effendy S , Sim CH , Lee JM , Chen I , Hia SB , Xue HL , Corrales MP , Chang HM , Wong MC , Chen CP , Tan EK . A r and omized controlled trial of rivastigmine in patients with cognitive impairment no dementia because of cerebrovascular disease . Acta Neurol Sc and : 2010 : 121 : 217–224 . © 2009 The Authors Journal compilation © 2009 Blackwell Munksgaard This article reports the development and psychometric properties of the Alzheimer 's Disease Cooperative Study - Clinical Global Impression of Change ( ADCS-CGIC ) . At present , a number of unvali date d CGIC scales are used in clinical trials , with various methods for making ratings . The ADCS-CGIC was design ed on the basis of a survey of ADCS clinicians and by adapting existing instruments . It includes an organized but unstructured format , with which a clinician can address clinical ly relevant change . The instrument 's reliability and validity were assessed in a prospect i ve trial of Alzheimer 's disease ( AD ) and healthy subjects over a 12-month period . It showed good short-term reliability at 1 and 2 months , with 90 and 94 % of AD subjects , respectively , rated as having changed not at all or only minimally . The ADCS-CGIC 's face validity was demonstrated by untreated . AD subjects rated as having worsened over time at both 6 months ( 56 % rated as having worsened ) and 12 months ( 81 % rated as having worsened ) , whereas only 2 % of control subjects showed minimal worsening . As a measure of predictive validity , ADCS-CGIC ratings at 12 months were significantly associated with change on four severity scales . As with other measures , change ratings were sensitive to dementia severity . Moderately impaired subjects showed greater worsening than other subjects . ADCS-CGIC ratings of greater worsening were made after the informant interview , regardless of whether informants or subjects were interviewed first . The ADCS-CGIC is a valid and reliable instrument for use in clinical trials We developed a set of informant-based items describing performance of activities of daily living ( ADL ) by patients with Alzheimer 's disease ( AD ) to identify which ADL are useful for assessment of patients in clinical trials . Evaluation of ADL is an important outcome measure in AD clinical trials . For clinical trial measurement , ADL should have broad applicability , good test-retest reliability , scaling to cover a range of performance , and sensitive to detect change in disease progression . A total of 45 ADL items developed from literature review and clinical experience were administered to informants of 242 AD patients and 64 elderly controls as part of the multicenter Alzheimer 's Disease Cooperative Study Instrument protocol . Half of the subjects were re-evaluated at 1 and 2 months and all at 6 and 12 months . Controls performed virtually all ADL items optimally at baseline and at 12 months . Among subjects with AD , 27 of the 45 ADL were widely applicable , i.e. , performed at baseline or premorbidly by > 90 % of subjects ; showed good test-retest reliability between baseline and 1 and 2 months ; correlated with MMSE scores of AD patients cross-sectionally ; and showed a decline in performance from baseline to 12 months in at least 20 % of AD patients . ADL could be identified that capture change in functional ability in patients across the entire range of the MMSE . The remaining 18 ADL included several that may be useful for trials that target specific population s , e.g. , women with AD . Because change on specific items depends on baseline MMSE , ADL evaluation should include items relevant to the severity of dementia of patients enrolled in a clinical trial Recent data indicate that patients with vascular dementia ( VaD ) show a cholinergic deficit . Having obtained good results in a previous study comparing rivastigmine , an inhibitor of acetylcholinesterase ( AChE ) and butyrylcholine-sterase ( BuChE ) , vs. aspirin , we aim ed to compare the efficacy and tolerability of rivastigmine vs. aspirin plus nimodipine . Patients with a diagnosis of dementia and probable VaD received rivastigmine 3 - 6 mg/day ( n = 32 ) or aspirin plus nimodipine ( n = 32 ) in an open study for 16 months . Patients treated with rivastigmine showed superior benefits , compared with those receiving aspirin plus nimodipine , in attention , executive function , instrumental activities of daily living , and behavioural and psychotic disturbances . Side-effects in both groups were tolerable and there were no study withdrawals . The benefits observed with rivastigmine may reflect its inhibitory effects on AChE and BuChE , and the drug Output:	Primary and secondary outcome measures showed no statistically significant difference when considering neurocognitive abilities , function , neuropsychiatric symptoms and global performance . Rivastigmine is capable of inducing side effects that lead to withdrawal in a significant proportion of patients
MS2606	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND & AIMS Nasogastric feeding may result in gastro-oesophageal reflux and , therefore , increase the risk of aspiration . This may be greater when feeds are administered via a bolus than by infusion . We aim ed to measure gastric emptying time and quantify gastro-oesophageal reflux in healthy volunteers given a liquid feed via an oral bolus ( OB ) , a nasogastric tube bolus ( TB ) and a nasogastric tube drip ( TD ) . METHODS Twelve male volunteers participated in three separate studies ( OB , TB and TD ) in r and om order , each 3 days apart . The feed consisted of 220 ml Ensure Plus ( 1.5 kcal/ml ) , labelled with 12 MBq (99m)Tc DTPA . The OB and TB were given over 5 min and the infusion rate for the TD was 55 ml/h . Gastric emptying time was measured using gamma scintigraphy . Gastro-oesophageal reflux was observed continuously until the stomach was empty , using a multichannel intraluminal impedance catheter . RESULTS Mean ( 95 % CI ) T(50 ) gastric emptying times for the OB and TB studies were 41.3 ( 36.5 - 46.2 ) min and 36.2 ( 30.6 - 41.8 ) min respectively ( p=0.19 ) . The stomach emptied at a rate equal to the infusion rate in the TD studies . Median ( IQR ) number of reflux episodes for the OB , TB and TD studies were 4.5 ( 2.0 - 6.0 ) , 3.0 ( 2.0 - 4.75 ) and 2.0 ( 0.25 - 6.25 ) respectively . Median ( IQR ) total duration of reflux for the OB , TB and TD studies were 38 ( 20 - 242 ) , 49 ( 17 - 71 ) and 36 ( 1 - 125 ) s respectively ( p = NS ) . CONCLUSIONS The lack of difference in gastro-oesophageal reflux between bolus and continuous feeding indicates that in healthy volunteers both methods are equally safe with respect to the risk of aspiration BACKGROUND Nearly 90 - 95 % of children with drool have physiologic gastroesophageal reflux ( GER ) that usually resolves by 12 - 15 months of age ; however , 5 - 10 % of children with drool have pathologic GER . Of these children , most recover clinical ly by 18 months of age without therapy , yet 10 % develop chronic , recurrent gastroesophageal reflux disease ( GERD ) with sequelae . The respiratory symptoms associated with GER consist mainly of bronchial asthma and laryngospasm , but often include a persistent cough of unknown aetiology , obstructive apnoea , and an obstructive respiratory syndrome confined to the nasopharynx . Gastric acid reflux , enters the adenoids , causes oedema of the tubal orifices , and later leads to relapsing diseases of the middle ear in children . AIM AND SCOPE To evaluate the incidence of otologic manifestations in children with GER and the efficacy of treatment , comparing two different groups of children ( i.e. , treated versus untreated ) . SUBJECTS AND METHODS From January 2005 to November 2006 , audiologic screening of newborns and suckling children ( 0 - 24 months of age ) at risk for auditory illnesses was held at the University Department of Otolaryngology in Catania . Seventy-three children ( average age , 13 months ) were selected after failing acoustic otoemissions for chronic bilateral catarrhal pathology involving the middle ear ( tympanometry type B ) and were positive for at least one of the different signs of GER at the time of history-taking . The children were r and omised and subdivided into two groups : ( 1 ) a group of 40 children ( 27 females and 13 males ; average age , 12 months ) who received treatment ; and ( 2 ) a group of 29 children ( 16 males and 13 females ; average age , 14 months ) who did not receive treatment . Four children were lost to follow-up after completing the study . All children enrolled in the study underwent a rhinopharynxlaryngeal fibroscopy with flexible optics , a gastric ultrasound scan after clinical observation , and a multi-channel pH-metry for 18 - 24h . RESULTS Findings obtained by rhinopharynxlaryngeal fibroscopy showed that 82 % of cases had diffuse hyperaemia involving the entire rhinopharyngeal mucosa and 13 % of the cases had arytenoidal hyperaemia . Resolution and improvement of the reflux occurred in 52.5 and 40 % of the cases in the treated group , respectively , versus complete resolution and an improvement in symptoms of 45 and 30 % of cases , respectively , in the control group . CONCLUSIONS The hypothesis of a correlation between reflux and chronic middle otitis of the serous-mucous type was confirmed in the present study . Adopting a preventive treatment strategy may be useful in reducing the possibility of ear involvement We compared two feeding regimens , continuous intragastric feedings and intermittent oral feeding , in nine infants with protracted diarrhea and malnutrition and two infants with surgically created short bowel . Continuous nasogastric feeding caused significant increases in enteral balance of the major nutrients , whereas intermittent feedings result ed in negative or only slightly positive enteral balance . The improvements in enteral balance from intermittent to continuous feeding in infants with diarrhea were as follows : Fat from 13 + /- 0.8 to 22 + /- 2.0 gm/24 hours ; nitrogen from 0.63 + /- 0.2 to 1.7 + /- 0.2 gm/24 hours ; calcium from -63 + /- 20 to 145 + /- 4 mg/24 hours ; zinc from -0.57 + /- 0.2 to 1.3 + /- 0.2 mg/24 hours ; and copper from -0.09 + /- 0.03 to 0.21 + /- 0.02 mg/24 hours . There was also a significant increase in body weight during the continuous feeding ( 168 + /- 16 gm/72 hours ) as compared to the intermittent feeding ( -171 + /- 26 gm/72 hours ) . Similar improvements in enteral balance were seen in the two infants with short bowel . These findings document that improved enteral balance can be achieved with continuous feeding in infants with bowel disease Nutritional benefits and feeding-related complications were prospect ively compared in 53 preterm very-low-birth-weight infants receiving isoenergetic feeding by either the continuous nasogastric ( n = 30 ) or intermittent nasogastric ( n = 23 ) route . Stepwise regression techniques were used to develop models relating feeding-associated factors . Feeding method significantly affected weight gain in infants 1000 to 1249 g birth weight with continuous nasogastric feeding associated with an additional weight gain of 3.6 to 6.1 g/kg/d . No effects of feeding method on changes in occipitofrontal circumference , triceps skin-fold thickness , bilirubin values , or total protein values were demonstrable . There were few major differences between feeding groups on measures of feeding complications . Continuous nasogastric feeding was fairly well tolerated and result ed in improved weight gain when compared with intermittent nasogastric feeding in preterm infants 1000 to 1249 g birth weight OBJECTIVE To compare the effects of continuous versus intermittent feeding on gastrointestinal tolerance and growth in very low birth weight ( VLBW ) infants . STUDY DESIGN In a r and omized , controlled trial conducted at 3 neonatal units , 70 premature infants with a gestational age 24 to 29 weeks and birth weight < 1200 g were assigned to 1 of 3 feeding methods : continuous nasogastric feeding , intermittent nasogastric feeding , or intermittent orogastric feeding . Feeding was initiated within 30 hours of birth . Daily enteral and parenteral volumes , caloric and protein intakes , growth , enteral intolerance , and clinical complications were recorded . Cox regression analysis was used to determine primary outcome , the time to achieve full enteral feeding . RESULTS The continuously fed infants achieved full enteral feeding significantly faster than the intermittently fed infants ( hazard ratio [ HR ] = 1.86 ; 95 % confidence interval [ CI ] = 1.07 to 3.22 ) . In stratified analysis according to birth weight , the improvement was even more pronounced in the smallest infants , those with birth weight < or = 850 g ( adjusted HR = 4.13 ; 95 % CI = 1.48 to 11.53 ) . Growth rate was significantly faster in the continuously fed infants ( P = .002 ) . CONCLUSION In VLBW infants , continuous feeding seems to be better than intermittent feeding with regard to gastrointestinal tolerance and growth Purpose : The aim of our study was to evaluate the relationship between gastric emptying and gastroesophageal reflux ( GER ) in infants and children . Methods and Material s : One hundred eight patients ( pts ) between 3 months and 5 years of age ( 77 boys , 31 girls ) with clinical suspicion of GER disease were included in the study . Patients were divided into 2 groups according to the age range : group A , 0–2 years ( 57 pts ) , and group B , 2–5 ( 51 pts ) years . Each group was divided into 2 subgroups according to the scintigraphic study as GER-positive and -negative . Cow 's milk with Tc-99 m sulfur colloid as radiotracer was used . Gastric emptying was expressed as the half emptying time ( T1/2 ) . The detection of activity in the esophagus at any time during scintigraphy was considered an indicator of GER episodes . Reflux episodes were grade d as grade 1 if activity was detected on one or 2 frames and grade 2 if activity was detected on more than 2 frames . Results : Forty of the 108 patients ( 37 % ) had GER findings on scintigraphy . The comparison of gastric emptying time between positive GER scintigraphy and negative GER scintigraphy groups was not statistically significant in any age group . No association was found between age and rate of gastric emptying time . Although the comparison of T1/2 between grade 1 patients and the GER-negative group was not statistically significant , grade 2 patients showed significant differences and had prolonged gastric emptying times . Mild statistical correlation between the number of reflux episodes and gastric emptying half time was found . Conclusions : As a conclusion , the relation between gastroesophageal reflux and delayed gastric emptying can not be ignored . Our results support delayed gastric emptying to be a pathogenetic factor in gastroesophageal reflux in infants and children The increased survival of sick and preterm neonates may be associated with long‐term problems which must be recognised and managed if outcome is to be optimised . In a prospect i ve study of 35 neonates ( median gestational age at birth 34 weeks ) admitted to a neonatal intensive care unit over a 3‐month period , we have documented a high incidence ( 14 of 35 ) of immature or abnormal feeding patterns when infants were assessed at 36 to 40 weeks postmenstrual age . Neonates with prolonged respiratory support and delayed enteral and oral feeding were most affected . Compared with neonates who have normal initial feeding assessment s , neonates with disorganised or dysfunctional feeding were six times more likely to vomit and three times more likely to cough when offered solid food at 6 months of age . At 12 months of age significant differences were also found in tolerating lumpy food and enjoying mealtimes . We hypothesise that these feeding problems contribute to failure to thrive and psychosocial distress after discharge from the neonatal unit and propose potential neonatal measures to reduce their incidence The National Institute of Child Health and Human Development conducts and supports research on all stages of human development from preconception to adulthood in order to better underst and the health of children , youths , adults , families , and communities . Health and human development information is made easily available on the site with a simple A to Z list , along with clinical trials and health education campaign information . Links to clinical trials , news releases , publications , and related web sites are also available , as well as information on research being conducted at present and supported by the National Institute of Child Health and Human Development OBJECTIVE To assess the efficacy of omeprazole in treating irritable infants with gastroesophageal reflux and /or esophagitis . STUDY DESIGN Irritable infants ( n=30 ) 3 to 12 months of age met the entry criteria of esophageal acid exposure > 5 % ( n=22 ) and /or abnormal esophageal histology ( n=15 ) . They completed a 4-week , r and omized , double-blind , placebo-controlled crossover trial of omeprazole . Cry/fuss diary ( minutes/24 hours ) and a visual analogue scale of infant irritability as judged by parental impression were obtained at baseline and the end of each 2-week treatment period . RESULTS The reflux index fell significantly during omeprazole treatment compared with placebo ( Output:	We did not identify any r and omised trials that evaluated the effects of continuous versus intermittent bolus intragastric tube feeding on gastro-oesophageal reflux disease in preterm and low birth weight infants .
MS2607	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The purpose of this study was to determine whether women in labor report less pain when they are in a vertical ( sitting or st and ing ) position than in a horizontal ( side-lying or supine ) position . Pain scores were obtained from 60 women in early labor ( dilation 2 - 5 cm ) who alternated between the two positions . The results show that about 35 % of women feel less front pain and 50 % feel less back pain when they are in a vertical position than in a horizontal position . The decrease in continuous back pain ( 83 % ) was particularly impressive , but the front and back pains associated with contractions were significantly diminished as well . These results , taken together with those of earlier studies , indicate that many women in early labor have less pain and are generally more comfortable in a vertical than in a horizontal position . Since early labor comprises a substantial proportion of the entire process of labor and delivery , any simple procedure which alleviates pain without danger to mother or child , such as shifting from a horizontal to a vertical position , should be promoted and employed There has been a relatively recent interest in alternative birthing techniques , including increased maternal mobility during labor . This literature review was pursued to evaluate the effect of upright maternal posture and ambulation on the first stage of labor . Although previous review s frequently assume that maternal ambulation speeds labor progress , the data presented in this review are not conclusive as to whether the upright maternal posture or ambulation during the first stage of labor shortens labor length or improves fetal outcome . However , it is clear that ambulation in labor is not harmful either to the mother or fetus . In addition , many investigators have reported that mobility in labor results in greater maternal comfort and ability to tolerate labor and decreased use of anesthesia and analgesia . Thus , acceptance of mobility in labor by patients and staff is generally reported . This information can serve as a guide to clinical management . However , there is a need for further analysis of the effect of maternal ambulation during labor , and specific suggestions for research are presented The cl aim that an upright maternal posture during labour improves the efficiency of the uterus to the benefit of both mother and fetus has been investigated in a r and omised prospect i ve study . 40 patients undergoing induction of labour were allocated to a recumbent group or an upright group . No differences were found between the groups in the length of labour , mode of delivery , requirements of oxytocic and analgesic drugs , or fetal and neonatal condition . Our data do not support calls to change conventional intrapartum nursing attitudes OBJECTIVE Our purpose was to test the hypothesis that the supine versus the lateral position is associated with a greater decrement in cardiac output after epidural analgesia in labor . STUDY DESIGN Twenty-one normal term subjects were r and omized to the left lateral or supine position in early labor . Cardiac output measured by the acetylene rebreathing method , stroke volume , heart rate , mean arterial pressure , and systemic vascular resistance were obtained at 5-minute intervals , beginning before a 500 ml intravenous fluid bolus ( baseline ) and ending 45 minutes after epidural injection . RESULTS Mean baseline supine versus lateral group differences were significant for 21 % lower cardiac output , 21 % lower stroke volume , 19 % higher mean arterial pressure , 50 % higher systemic vascular resistance , and equivalent heart rate . In the supine group fluid bolus result ed in significantly increased cardiac output and stroke volume , decreased mean arterial pressure and systemic vascular resistance , and unchanged heart rate . In the supine group cardiac output and stroke volume decreased significantly after epidural injection . The lateral position group exhibited no hemodynamic alterations after fluid bolus or epidural . CONCLUSIONS In contrast to the lateral position , the supine position is associated with a significant postepidural decrement in cardiac output , not identified by a change in heart rate . This likely reflects an inability to maintain stable preload volume in the supine position Telemetry and conventional cardiotocography were compared by monitoring the labor of 60 patients with an uneventful pregnancy and delivery in the 38th-42nd week of pregnancy . 31 patients were monitored by telemetry and 29 by cardiotocography . The patients were matched for age ( + /- 5 years ) , duration of pregnancy ( + /- 7 days ) and parity ( I or II ) . The husb and attended labor and delivery in 42 % of the cases in the telemetry group and in 59 % of the cases in the control group . Induction of labor by amniotomy was performed in 32 % of the cases in the telemetry group and in 24 % of the cases in the cardiotocography group . The patients monitored subjective pain every half hour during the opening phase . The telemetric patients were encouraged to sit or walk during the first stage . No maternal or fetal complications occurred . All infants were born in good condition with APGAR scores greater than or equal to 7 recorded at one and five minutes . There were 4 operative deliveries in the telemetry group and 5 in the control group . Indications for these were maternal or uterine exhaustion with the exception of two control patients where fetal asphyxia was suspected . The duration of the first stage of labor did not differ significantly between the telemetry and the cardiotocography groups . The telemetric patients received less analgesics than the controls but this difference was not significant . In spite of less analgesia in the telemetry group , the secondparas of the telemetry group experienced significantly less ( p less than 0.01 ) labor pain than the controls . In addition , the secondparas of the telemetry group considered the present labor less painful than the previous one significantly more often than the controls . Among the primiparous patients there was no difference in the amount of pain experienced by the patients Our purpose was to study the feasibility and results of encouraging ambulation during the first stage of labor in routine obstetric practice . Six-hundred and thirty low risk mothers with intact membranes were r and omized into an ambulant and a control group . The results in the ambulant group were not better than in the control group . Our study suggests that , in principle ambulation may be beneficial , but that the concomitant changes in practice should be different from those in our study A prospect i ve study of 300 consecutive deliveries has been made to assess the benefits and acceptability of ambulation during spontaneous labour . Ambulation during the first stage occurred in 48 patients with 55 non‐ambulant patients acting as controls . No difference in the length of first or second stage , incidence of fetal distress or mode of delivery was observed . In spite of the lack of apparent advantage to the fetal condition , ambulation was acceptable to both patients and nursing staff and should not be discouraged The purpose of this study was to determine if women who assumed upright positions during the phase of maximum slope would have a shorter phase of maximum slope in their labor and experience more comfort than women who assumed recumbent positions . Forty laboring women were r and omly assigned to either an upright or recumbent position group . Subjects assumed the positions of their assigned group during the phase of maximum slope in their labor ( cervical dilatation from 4 cm to 9 cm ) . Every hour during the phase of maximum slope , each subject was examined vaginally to determine her cervical dilatation and assessed for her level of comfort using the Maternal Comfort Assessment Tool . Women in the upright position group had a significantly shorter phase of maximum slope in labor , but did not significantly differ in comfort level from women in the recumbent group . Newborn Apgar scores were not significantly different between the two groups . Nurses need to be aware that the upright labor positions have the distinct advantages of facilitating efficient uterine contractions and reducing the duration of the phase of maximum slope in labor , with no increase in the discomfort experienced or adverse effect on newborn well-being Background Ambulatory epidural analgesia ( AEA ) is a popular choice for labor analgesia because ambulation reportedly increases maternal comfort , increases the intensity of uterine contractions , avoids inferior vena cava compression , facilitates fetal head descent , and relaxes the pelvic musculature , all of which can shorten labor . However , the preponderance of evidence suggests that ambulation during labor is not associated with these benefits . The purpose of this study is to determine whether ambulation with AEA decreases labor duration from the time of epidural insertion to complete cervical dilatation . Methods In this prospect i ve , r and omized study , 160 nulliparous women with AEA were r and omly assigned to one of two groups : AEA with ambulation and AEA without ambulation . AEA blocks were initiated with 15–20 ml ropivacaine ( 0.07 % ) plus 100 & mgr;g fentanyl , followed by a continuous infusion of 0.07 % ropivacaine plus 2 & mgr;g/ml fentanyl at 15–20 ml/h . Maternal measured variables included ambulation time , time from epidural insertion to complete dilatation , stage II duration , pain Visual Analogue Scale scores , and mode of delivery . APGAR scores were recorded at 1 and 5 min . Results are expressed as mean ± SD or median and analyzed using the t test , chi-square , or the Mann – Whitney test at P ≤ 0.05 . Results The ambulatory group walked 25.0 ± 23.3 min , sat upright 40.3 ± 29.7 min , or both . Time from epidural insertion to complete dilatation was 240.9 ± 146.1 min in the ambulatory group and 211.9 ± 133.9 min in the nonambulatory group ( P = 0.206 ) . Conclusion Ambulatory epidural analgesia with walking or sitting does not shorten labor duration from the time of epidural insertion to complete cervical dilatation Background The authors recently showed that “ mobile ” epidural analgesia , using low-dose local anesthetic-opioid mixtures , reduces the impact of epidural analgesia on instrumental vaginal delivery , relative to a traditional technique . The main prespecified assessment of pain relief efficacy , women 's postpartum estimates of labor pain after epidural insertion , did not differ . The detailed analgesic efficacy and the anesthetic characteristics of the techniques are reported here . Methods A total of 1,054 nulliparous women were r and omized , in labor , to receive boluses of 10 ml 0.25 % bupivacaine ( traditional ) , combined spinal-epidural ( CSE ) analgesia , or low-dose infusion ( LDI ) , the latter groups utilizing 0.1 % bupivacaine with 2 & mgr;g/ml fentanyl . Visual analog scale pain assessment s were collected throughout labor and delivery and 24 h later . Details of the conduct of epidural analgesia , drug utilization , and requirement for anesthesiologist reattendance were recorded . Results A total of 353 women were r and omized to receive traditional epidural analgesia , 351 received CSE , and 350 received LDI . CSE was associated with a more rapid onset of analgesia , lower median visual analog scale pain scores than traditional in the first hour after epidural insertion , and a significant reduction in bupivacaine dose given during labor . Pain scores reported by women receiving LDI were similar to those in the traditional group throughout labor and delivery . Anesthesiologist reattendance was low but greater with each mobile technique . Conclusions Relative to traditional epidural analgesia , LDI is at least as effective and CSE provided better pain relief in the early stages after insertion . The proven efficacy of mobile epidurals and their beneficial impact on delivery mode make them the preferred techniques for epidural pain relief in labor Published reports imply that intrapartum ambulation may improve labor . This suggests the possible efficacy of ambulation in labors requiring augmentation , provided that adequate monitoring surveillance is maintained . Fourteen patients who failed to progress in active-phase labor , and who required augmentation for " inadequate " contractions were r and omized into ambulation ( eight ) and oxytocin ( six ) groups . Internal fetal monitoring was used in all patients for 30 minute baseline and 2 hour study periods , with two-channel telemetry used in ambulating patients . Oxytocin was administered by infusion pump . Study parameters included changes in cervical dilation and station , contraction frequency , intensity and baseline tonus , and uterine activity . Labor progress was slightly but not significantly better in the ambulatory group . A mean increase in uterine activity units ( UAU ) in the ambulatory group was immediate to ranges not reached in the oxytocin group for 2 hours . Increase in Montevideo units was slightly greater in the ambulatory group during the first hour , but was exceeded by the oxytocin group during the second hour . These initial observations seem to indicate that , in terms of labor progress and initial effects on uterine activity , ambulation is as effective as oxytocin for the enhancement of labor and warrants further investigation Ambulation during labor is becoming more popular , although its impact on the progress of labor and on pain intensity remains unclear . We wondered whether prolonged ambulation with epidural analgesia had a possible effect on duration of labor and pain . In this prospect i ve , r and omized trial , 61 parturients with uncomplicated term pregnancies were allocated to be recumbent ( n = 31 ) or to ambulate ( n = 30 ) . Epidural analgesia was provided with intermittent administrations of 0.08 % bupivacaine-epinephrine plus 1 & mgr;g/mL of sufentanil . Of the 30 women assigned to the ambulatory group , 25 actually walked . Their ambulating time was 64 ± 34 min ( mean ± sd ) , i.e. , 29 % ± 16 % of the first stage . There were no differences between the two groups in the length of labor and in pain visual analog scale scores . However , the ambulatory group received smaller doses of bupivacaine ( 6.4 ± 2.2 mg/h versus 8.4 ± 3.6 mg/h ; P = 0.01 ) and of oxytocin ( 6.0 ± 3.7 mUI/min versus 10.2 ± 8.8 mUI/min ; P < Output:	For women who had epidural analgesia there were no differences between those r and omised to upright versus recumbent positions for any of the outcomes examined in the review . There is evidence that walking and upright positions in the first stage of labour reduce the length of labour and do not seem to be associated with increased intervention or negative effects on mothers ' and babies ' wellbeing .
MS2608	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This study develops and vali date s a novel patient-specific navigational template for total knee arthroplasty ( TKA ) . A total of 70 patients who underwent TKA were r and omized and divided into conventional method group and navigational template group . In the navigational template group , the patient-specific navigational templates were design ed and used intraoperatively to assist 35 patients with knee arthroplasty . Information on operation time and blood loss was recorded . After surgery , the positions of the prosthesis were evaluated using CT scan and X-rays . Analysis showed significant differences in errors between the two techniques . In addition , mean operation time and mean blood loss were statistically and significantly lower in the navigational template group than in the conventional group . Overall , the navigational template method showed a high degree of accuracy and efficacy BACKGROUND Sagittal split ramus osteotomy ( SSRO ) can be associated with postoperative neurosensory disturbances . This study aim ed to evaluate the effectiveness of computer-assisted SSRO in reducing the incidence and severity of neurosensory alterations , using a surgical guide fabricated by computer-aided design and rapid prototyping ( to guide bone cutting lateral to the inferior alveolar nerve ) . METHODS A prospect i ve double-blind , r and omized controlled , clinical trial of computer-assisted SSRO vs conventional SSRO ( assigned in a split-mouth design ) in eight patients , mean age 23 ( range 18 - 30 ) years , who participated in one session preoperatively and three sessions at 1 week and 1 , 3 and 6 months postoperatively . At each session , subjective oral sensation was scored and quantitative sensory tests were performed . Neurosensory changes were compared between the two sides . RESULTS The results showed that on the computer-assisted SSRO sides , patients had lower postoperative abnormal thresholds for the Semmes-Weinstein monofilaments on lower lip and chin ( p < 0.05 at 3 months ) and for the two-point discrimination on lower lip ( p < 0.05 at 1 week ) and chin ( p < 0.05 at 6 months ) , with fewer abnormal self-reported changes in lower lip sensation ( p < 0.05 at 1 week ) after surgery . CONCLUSIONS These findings imply that computer-assisted SSRO is associated with better levels of neurosensory function after surgery Objective : To investigate the efficacy of 3-D printed bone models as a tool to facilitate initiation of bisphosphonate treatment among individuals who were newly diagnosed with osteoporosis . Design : Fifty eight participants with estimated fracture risk above that at which guidelines recommend pharmacological intervention were r and omised to receive either a st and ard physician interview or an interview augmented by the presentation of 3-D bone models . Main outcome measures : Participants ’ beliefs about osteoporosis and bisphosphonate treatment , initiation of bisphosphonate therapy assessed at two months using self-report and pharmacy dispensing data . Results : Individuals in the 3-D bone model intervention condition were more emotionally affected by osteoporosis immediately after the interview ( p = .04 ) and reported a greater underst and ing of osteoporosis at follow-up ( p = .04 ) , than the control group . While a greater proportion of the intervention group initiated an oral bisphosphonate regimen ( alendronate ) ( 52 % ) in comparison with the control group ( 21 % ) , the overall initiation of medication for osteoporosis , including infusion ( zoledronate ) , did not differ significantly ( intervention group 62 % , control group 45 % , p = .19 ) . Conclusion : The presentation of 3-D bone models during a medical consultation can modify cognitive and emotional representations relevant to treatment initiation among people with osteoporosis and might facilitate commencement of bisphosphonate treatment Purpose Due to the complexity of acetabulum , achieving anatomical contouring intra-operatively is difficult for surgeon . A 3D ( dimensional ) real model can facilitate us both in contouring the plate pre-operatively and in better pre-operative planning . Patient-specific pre-contoured plate in acetabular fracture has been studied by few research ers but r and omized case – control study was lacking . Hence , we conducted a case – control study to evaluate the accuracy of patient-specific pre-contoured plate . Material s and methods Prospect i ve r and omized case control study was conducted . 21 patients were included . 10 patients were distributed in “ case ” group and remaining 11 in “ control ” group . Inclusion criteria : Displaced acetabulum fractures with displacement of ≥3 mm in adults who reported within 3 weeks of injury . Exclusion criteria were : Open fractures , associated Morel-Lavallée lesion and patients with > 3 weeks old fracture . In case group , patient-specific real 3D model of fractured acetabulum was generated using rapid prototyping technology and plates were contoured pre-operatively . Control group was treated using intra-operative contoured plates . Both the groups were compared using parameters : Blood loss , Surgery time , post-operative reduction on X-ray , post-surgical residual displacement and reduction achieved as evaluated by CT scan . Results Reduced blood loss ( 100 ml less in case group ) and surgical time ( 12 min less in case group ) and better post-operative reduction were observed in case than control . In control group , 4 patients even had step of 2–3 mm , which was not seen in case group . All the pre-contoured plates fitted well to the pelvis intra-operatively . Reduction achieved as evaluated by CT was more in “ case ” group with statistically significant outcomes ( p < 0.05 ) . Conclusion Patient-specific pre-contoured plate made using 3D model is a better implant than intra-operatively contoured plate . Real-time 3D pelvis model is an accurate technique for pre-operative planning in acetabular fractures Prototyping technologies for reconstructions consist of obtaining a 3‐dimensional model of the object of interest . Solid models are constructed by the deposition of material s in successive layers . The purpose of this study was to perform a double‐blind , r and omized , prospect i ve study to evaluate the efficacy of prototype use in head and neck surgeries Background Computer-assisted surgery plays an increasingly important role in m and ibular reconstruction , ensuring the best possible masticatory function and aesthetic outcome . Methods Twenty patients were r and omly assigned to computer-assisted or conventional m and ibular reconstruction with vascularized iliac crest bone graft in a prospect i ve study design .Virtual surgical planning was based on preoperative CT- data using specific surgical planning software . A rapid prototyping guide transferred the virtual surgery plan to the operation site . During surgery the transplant ischemic time , reconstruction time , time for shaping the transplant and amount of bone removed were measured . Additionally , the difference in the intercondylar distance before and after surgery was calculated . Results Computer-assisted surgery shortened the time of transplant ischemia ( P < 0.005 ) and defect reconstruction ( P < 0.001 ) compared to conventional surgery . The time to saw and shape the transplant at the donor site was shorter using conventional surgery ( P < 0.005 ) ; therefore , the overall time for surgery did n’t change ( P = 0.527 ) . In the computer-assisted group , the amount of bone harvested equaled the defect size , whereas the transplant size in the conventional group exceeded the defect site by 16.8 ± 5.6 mm ( P < 0.001 ) on average . The intercondylar distance before compared to after surgery was less affected in the computer-assisted than in the conventional group ( P < 0.001 ) . Conclusions The presented study shows that computer-assisted surgery can help reduce the time for m and ibular defect reconstruction and consequently the transplant ischemic time . In the computer-assisted group , the iliac crest donor site defect was downsized and the postoperative condyle position was less altered , reducing possible risks of postoperative complications and donor site morbidity . Trial Registration Abstract The aim of the study was to evaluate the efficacy custom 3D-printed osteo synthesis plates in the treatment of intercondylar humeral fractures . Thirteen patients with distal intercondylar humeral fractures were r and omized to undergo surgery using either conventional plates ( n = 7 ) or 3D-printed plates ( n = 6 ) at our institution from March to October 2014 . Both groups were compared in terms of operative time and elbow function at 6 month follow-up . All patients were followed-up for a mean of 10.6 months ( range : 6–13 months ) . The 3D-printing group had a significantly shorter mean operative time ( 70.6 ± 12.1 min ) than the conventional plates group ( 92.3 ± 17.4 min ) . At the last follow-up period , there was no significant difference between groups in the rate of patients with good or excellent elbow function , although the 3D-printing group saw a slightly higher rate of good or excellent evaluations ( 83.1 % ) compared to the conventional group ( 71.4 % ) . Custom 3D printed osteo synthesis plates are safe and effective for the treatment of intercondylar humeral fractures and significantly reduce operative time To evaluate the effect of 3D printing in treating trimalleolar fractures and its roles in physician-patient communication , thirty patients with trimalleolar fractures were r and omly divided into the 3D printing assisted- design operation group ( Group A ) and the no-3D printing assisted- design group ( Group B ) . In Group A , 3D printing was used by the surgeons to produce a prototype of the actual fracture to guide the surgical treatment . All patients underwent open reduction and internal fixation . A question naire was design ed for doctors and patients to verify the verisimilitude and effectiveness of the 3D-printed prototype . Meanwhile , the operation time and the intraoperative blood loss were compared between the two groups . The fracture prototypes were accurately printed , and the average overall score of the verisimilitude and effectiveness of the 3D-printed prototypes was relatively high . Both the operation time and the intraoperative blood loss in Group A were less than those in Group B ( P < 0.05 ) . Patient satisfaction using the 3D-printed prototype and the communication score were 9.3 ± 0.6 points . A 3D-printed prototype can faithfully reflect the anatomy of the fracture site ; it can effectively help the doctors plan the operation and represent an effective tool for physician-patient communication BACKGROUND The considerable variation in anatomical abnormalities of hip joints associated with different types of developmental dysplasia of hip ( DDH ) makes reconstruction in total hip arthroplasty ( THA ) difficult . It is desirable to create patient-specific design s for THA procedures . In the cases of adult single DDH , an accuracy-improved method has been developed for acetabular cup prosthesis implantation of hip arthroplasty . METHODS From October 2007 to November 2008 , 22 patients with single DDH ( according to the Crowe st and ard , all dysplasia hips were classified as type I ) were scanned with spiral CT pre-operatively . These patients scheduled for THA were r and omly assigned to undergo either conventional THA ( control group , n = 11 ) or navigation template implantation ( NT group , n = 11 ) . In the NT group , three-dimensional ( 3D ) CT pelvis image data were transferred to a computer workstation and 3D models of the hip were reconstructed using the Mimics software . The 3D models were then processed by the Imageware software . In brief , a template that best fitted the location and shape of the acetabular cup was ' reversely ' built from the 3D model , the rotation centre of the pathological hip determined by mirroring that of the healthy site , and a guiding hole in the template was then design ed . The navigational templates were manufactured using a rapid prototyping machine . These navigation templates guide acetabular component placement . RESULTS Based on the predetermined abduction angle 45 ° and anteversion angle 18 ° , after 1 year follow-up , the NT group showed significantly smaller differences ( 1.6 ° ± 0.4 ° , 1.9 ° ± 1.1 ° ) from the predetermined angles than those in the control group ( 5.8 ° ± 2.9 ° , 3.9 ° ± 2.5 ° ) ( P < 0.05 ) . CONCLUSIONS The template design s facilitated accurate placement of acetabular components in dysplasia of acetabulum . The hip 's center of rotation in DDH could be established using computer-aided design , which provides a useful method for the accurate location of prosthesis with a low cost-performance ratio without excessive technical workload on the surgical team OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Output:	The main benefits of these devices were decreased surgical operation times and increased surgical accuracy . CONCLUSIONS All medical fields that assessed 3D-printed devices concluded that they were clinical ly effective . The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system , both of which concluded that the 3D-printed devices outperformed their conventional comparators . However , the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields .
MS2609	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective To evaluate the potential clinical , metabolic , and economic advantages of enteral nutrition over total parenteral nutrition . Design Prospect i ve , r and omized clinical trial . Setting Department of surgery in a university hospital . Patients Two hundred and fifty-seven patients with cancer of the stomach ( n = 121 ) , pancreas ( n = 110 ) , or esophagus ( n = 26 ) were r and omized to receive postoperative total parenteral nutrition ( TPN group , n = 131 ) or early enteral nutrition ( EEN group , n = 126 ) . The nutritional goal was 25 kcal/kg/day . The two nutritional formulas were isocaloric and isonitrogenous , and they were continued until oral intake was at least 800 kcal/day . Measurements Morbidity , mortality , length of hospital stay , and treatment costs were evaluated in all patients . In 40 consecutive patients , selected nutritional , immunologic and inflammatory variables were studied . Moreover , intestinal oxygen tension was evaluated by micropolarographic implantable probes . Main Results The nutritional goal was reached in 100/126 ( 79.3 % ) patients in the EEN group and in 128/131 ( 97.7 % ) patients in the TPN group ( p < .001 ) . In the EEN group , hyperglycemia ( serum glucose , > 200 mg/dL ) was observed in 4.7 % of the patients vs. 9.1 % in the TPN group ( p = NS ) . Alteration of serum electrolyte levels was 3.9 % in the EEN group vs. 13.7 % in the TPN group ( p < .01 ) . No significant difference was found in nutritional , immunologic , and inflammatory variables between the two groups . The overall complication rate was similar ( 40.4 % for TPN vs. 35.7 % , for EEN;p = .52 ) . No difference was detected for either infectious or noninfectious complications , length of hospital stay , and mortality . From postoperative day 5 , intestinal oxygen tension recovered faster in the EEN group than in the TPN group ( 43 ± 5 mm Hg vs. 31 ± 4 mm Hg at day 7;p < .001 ) . EEN was four-fold less expensive than TPN ( $ 25 vs. $ 90.60/day , respectively ) . Conclusion EEN represents a rational alternative to TPN in patients who undergo upper gastrointestinal tract surgery for cancer and who clinical ly require postoperative artificial nutrition Objectives : To investigate direct postoperative outcome and plasma amino acid concentrations in a study comparing early enteral nutrition versus early parenteral nutrition after major rectal surgery . Previously , it was shown that a low plasma glutamine concentration represents poor prognosis in ICU patients . Design : A preplanned sub study of a previous prospect i ve , r and omized , open-label , single-centre study , comparing early enteral nutrition versus early parenteral nutrition in patients at high risk of postoperative ileus after surgery for locally advanced or locally recurrent rectal cancer . Early enteral nutrition reduced postoperative ileus , anastomotic leakage , and hospital stay . Setting : Tertiary referral centre for locally advanced and recurrent rectal cancer . Patients : A total of 123 patients with locally advanced or recurrent rectal carcinoma requiring major rectal surgery . Interventions : Patients were r and omized ( ALEA web-based external r and omization ) preoperatively into two groups : early enteral nutrition ( early enteral nutrition , intervention ) by nasojejunal tube ( n = 61 ) or early parenteral nutrition ( early parenteral nutrition , control ) by jugular vein catheter ( n = 62 ) . Eight hours after the surgical procedure artificial nutrition was started in hemodynamically stable patients , stimulating oral intake in both groups . Blood sample s were collected to measure plasma glutamine , citrulline , and arginine concentrations using a vali date d ultra performance liquid chromatography-t and em mass spectrometric method . Measurements and Main Results : Baseline concentrations were comparable for both groups . Directly after rectal surgery , a decrease in plasma amino acids was observed . Plasma glutamine concentrations were higher in the parenteral group than in the enteral group on postoperative day 1 ( p = 0.027 ) and day 5 ( p = 0.008 ) . Arginine concentrations were also significantly increased in the parenteral group at day 1 ( p < 0.001 ) and day 5 ( p = 0.001 ) . Conclusions : Lower plasma glutamine and arginine concentrations were measured in the enteral group , whereas a better clinical outcome was observed . We conclude that plasma amino acids do not provide a causal explanation for the observed beneficial effects of early enteral feeding after major rectal surgery Gut malnutrition in patients with persistent hypermetabolism is hypothesized to be an important factor in postseptic multiple organ failure syndrome ( MOFS ) . The hypothesis was made that enteral nutrition ( EN ) started at the onset of hypermetabolism could reduce the incidence of MOFS . Sixty-six patients with persistent hypermetabolism 4 to 6 days after onset of sepsis were prospect ively r and omized to receive either parenteral nutrition ( PN ) or enteral nutrition ( EN ) at 1.5 gm protein/kg/day and 30 nonprotein calories/kg/day ; the EN and TPN were of the same composition . There was no reduction in either the incidence of MOFS or mortality attributable to the route of nutrition administration . The PN group tended to have better visceral protein support ; the EN group had more gut complications . When analyzed , the type of formula given did have an effect on the nutritional outcome but not on the mortality rate . A formula with a nonprotein-calorie-to-nitrogen ratio of 100:1 was associated with more nitrogen retention , higher levels of visceral proteins , and better gut tolerance . The route of nutrition administration does not seem to affect the incidence of postseptic MOFS or mortality when hypermetabolism is already present and when commercially available nutritional formulas are used . The relationships among the route of nutrition , the type of enteral formula , and the disease process of hypermetabolism and MOFS appear to be complex and require much more investigation before the role of the gut and enteral nutrition can be defined OBJECTIVE To develop a model of established respiratory immunity against Pseudomonas aeruginosa pneumonia and to investigate the effects of route and type of nutrition on this immunity . SUMMARY BACKGROUND DATA Diet influences the ability of gut-associated lymphoid tissue ( GALT ) to maintain mucosal immunity . Complex enteral diets and chow maintain normal GALT population s against established IgA-mediated antiviral respiratory immunity . Both intravenous and intragastric total parenteral nutrition ( TPN ) produce GALT atrophy , but only intragastric TPN preserves established antiviral immunity . The authors hypothesized that both GALT-depleting diets ( intragastric and intravenous TPN ) would impair immunity against bacterial pneumonia . METHODS P. aeruginosa was administered intratracheally to determine the mortality rate at increasing doses , and liposomes containing P. aeruginosa antigens were used to generate effective respiratory immunization . In the final experiment , mice received liposomes containing P. aeruginosa antigens to establish immunity and then were r and omized to chow , complex enteral diets , intragastric TPN , or intravenous TPN . After 5 days of diet , mice received live intratracheal P. aeruginosa , and the death rate was recorded at 24 and 48 hours . RESULTS The LD50 and LD100 were 9 x 10(7 ) and 12 x 10(7 ) , respectively . Immunization reduced the mortality rate from 66 % to 12 % . This immunization was maintained in mice fed chow or a complex enteral diet and was lost in animals receiving intravenous TPN . Intragastric TPN partially preserved this respiratory immunity . CONCLUSIONS Protection against bacterial pneumonia can be induced by prior antigenic immunization . This protection is lost with intravenous TPN , partially preserved with a chemically defined enteral diet , and completely preserved with chow or complex enteral diets . Both route and type of nutrition influence antibacterial respiratory tract immunity Abstract Purpose We assessed the effects of early goal -directed nutrition ( EGDN ) vs. st and ard nutritional care in adult intensive care unit ( ICU ) patients . Methods We r and omised acutely admitted , mechanically ventilated ICU patients expected to stay longer than 3 days in the ICU . In the EGDN group we estimated nutritional requirements by indirect calorimetry and 24-h urinary urea aim ing at covering 100 % of requirements from the first full trial day using enteral and parenteral nutrition . In the st and ard of care group we aim ed at providing 25 kcal/kg/day by enteral nutrition . If this was not met by day 7 , patients were supplemented with parenteral nutrition . The primary outcome was physical component summary ( PCS ) score of SF-36 at 6 months . We performed multiple imputation for data of the non-responders . Results We r and omised 203 patients and included 199 in the intention-to-treat analyses ; baseline variables were reasonably balanced between the two groups . The EGDN group had less negative energy ( p < 0.001 ) and protein ( p < 0.001 ) balances in the ICU as compared to the st and ard of care group . The PCS score at 6 months did not differ between the two groups ( mean difference 0.0 , 95 % CI −5.9 to 5.8 , p = 0.99 ) ; neither did mortality , rates of organ failures , serious adverse reactions or infections in the ICU , length of ICU or hospital stay , or days alive without life support at 90 days . Conclusions EGDN did not appear to affect physical quality of life at 6 months or other important outcomes as compared to st and ard nutrition care in acutely admitted , mechanically ventilated , adult ICU patients . Clinical trials.gov identifier no. NCT01372176 We measured energy expenditure ( MREE ) and nitrogen excretion ( UUN ) in patients with severe head injury r and omized to early parenteral ( TPN , n = 21 ) or jejunal ( ENT , n = 27 ) feeding with identical formulations . The MREE rose to 2400 + /- 531 kcal/day in both groups and remained at 135 % + /- 26 % to 146 % + /- 42 % of predicted energy expenditure over 4 weeks . Nitrogen excretion peaked the second week at 33.4 + /- 10 ( TPN ) and 31.2 + /- 7.5 ( ENT ) g N/day . Both routes were equally effective at meeting nutritional goals ( 1.2 x MREE , 2.5 g protein/kg/day intake , stabilized albumin and transferrin levels ) . Infections were equally frequent : 1.86 episodes/TPN patient versus 1.89 episodes/ENT patient . While patient charges were much greater for TPN , the hospital costs were similar for TPN and ENT support regimens . These findings show that patients with head injuries are hypermetabolic for weeks , that only 27 % are capable of spontaneously eating nutritional requirements by discharge , and that either TPN or ENT support is equally effective when prescribed according to individual measurements of MREE and nitrogen excretion Background Nutrition is one of the fundamentals of care provided to critically ill adults . The volume of enteral nutrition received , however , is often much less than prescribed due to multiple functional and process issues . To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone , parenteral nutrition can be used in combination ( termed “ supplemental parenteral nutrition ” ) , but benefits of this method have not been firmly established . A multi-centre , r and omised , clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill . Methods / design This prospect i ve , multi-centre , r and omised , stratified , parallel-group , controlled , phase II trial aims to determine whether a supplemental parenteral nutrition strategy will reliably and safely increase energy intake when compared to usual care . The study will be conducted for 100 critically ill adults with at least one organ system failure and evidence of insufficient enteral intake from six intensive care units in Australia and New Zeal and . Enrolled patients will be allocated to either a supplemental parenteral nutrition strategy for 7 days post r and omisation or to usual care with enteral nutrition . The primary outcome will be the average energy amount delivered from nutrition therapy over the first 7 days of the study period . Secondary outcomes include protein delivery for 7 days post r and omisation ; total energy and protein delivery , antibiotic use and organ failure rates ( up to 28 days ) ; duration of ventilation , length of intensive care unit and hospital stay . At both intensive care unit and hospital discharge strength and health-related quality of life assessment s will be undertaken . Study participants will be followed up for health-related quality of life , re source utilisation and survival at 90 and 180 days post r and omisation ( unless death occurs first ) . Discussion This trial aims to determine if provision of a supplemental parenteral nutrition strategy to critically ill adults will increase energy intake compared to usual care in Australia and New Zeal and . Output:	AUTHORS ' CONCLUSIONS We found insufficient evidence to determine whether EN is better or worse than PN , or than combined EN and PN for mortality in hospital , at 90 days and at 180 days , and on the number of ventilator-free days and adverse events . We found fewer deaths at 30 days when studies gave combined EN and PN , and reduced sepsis for EN rather than PN .
MS2610	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE The purpose of this study was to evaluate associations between hormonal therapy for breast cancer and subsequent diabetes incidence . METHODS The Surveillance , Epidemiology and End Results -Medicare linked data were used . Stage I-III breast cancer patients 65 years or older who filled at least two prescriptions for an aromatase inhibitor ( AI ) or tamoxifen by the end of 2008 , and within 12 months of breast cancer diagnosis , were selected . Women without cancer from a 5 % r and om sample of Medicare beneficiaries were frequency matched to patients by age group , and new onset diabetes was monitored for 24 months postbaseline in both groups of women . RESULTS Cox-proportional hazards analysis failed to show an association between AI use and subsequent diabetes onset after adjusting for age , race , and comorbidity ( hazard ratio : 0.99 ; 95 % confidence interval : 0.84 - 1.18 ) . This study also failed to show an association between tamoxifen use and diabetes onset ( hazard ratio : 0.79 ; 95 % confidence interval : 0.54 - 1.17 ) . CONCLUSIONS Study findings provide evidence that postmenopausal AI and tamoxifen users do not experience an increased risk of diabetes in the 2 years after treatment initiation . Whether these findings will hold with longer duration follow-up deserves a closer look PURPOSE Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer . The Exercise and Nutrition to Enhance Recovery and Good Health for You ( ENERGY ) study is the largest weight loss intervention trial among survivors of breast cancer to date . METHODS In this multicenter trial , 692 overweight/obese women who were , on average , 2 years since primary treatment for early-stage breast cancer were r and omly assigned to either a group-based behavioral intervention , supplemented with telephone counseling and tailored newsletters , to support weight loss or a less intensive control intervention and observed for 2 years . Weight and blood pressure were measured at 6 , 12 , 18 , and 24 months . Longitudinal mixed models were used to analyze change over time . RESULTS At 12 months , mean weight loss was 6.0 % of initial weight in the intervention group and 1.5 % in the control group ( P<.001 ) . At 24 months , mean weight loss in the intervention and control groups was 3.7 % and 1.3 % , respectively ( P<.001 ) . Favorable effects of the intervention on physical activity and blood pressure were observed . The weight loss intervention was more effective among women older than 55 years than among younger women . CONCLUSION A behavioral weight loss intervention can lead to clinical ly meaningful weight loss in overweight/obese survivors of breast cancer . These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival OBJECTIVE To evaluate insulin values , insulin resistance , growth factors and cytokine levels in women suffering from breast cancer and the effect of chemotherapy on these parameters . DESIGN In a prospect i ve study , glucose and insulin values were determined in ten previously undiagnosed diabetic postmenopausal women with stage IV breast cancer ( hepatic metastases excluded ) during an oral glucose tolerance test ( OGTT ) carried out after a glucose load of 75 g. At baseline , leptin , Interleukin-1 ( IL-1 ) , Interleukin-6 ( IL-6 ) , Interleukin-8 ( IL-8 ) , Insulin-Growth Factor-1 ( IGF-1 ) , Tumor-Necrosis-Factor-alpha ( TNF-alpha ) , Vascular Endothelial Growth Factor ( VEGF ) and Platelet Derived Growth Factor ( PDGF ) levels were also determined using appropriate method olody . Insulin resistance and beta-cell function were calculated ( HOMA-model ) . All women were evaluated prior to and after chemotherapy applied for 6 months . RESULTS 1 ) Insulin levels at 120 minutes of the OGTT were higher before compared to post-chemotherapy ( Mean+/-SD : 170.39+/-78.07 vs 111.75+/-76.19 , p=0.037 ) . 2 ) Body mass index ( BMI ) was an important predictor of post-glucose load insulin levels both before ( coefficient=1.051 , p=0.004 ) and after chemotherapy ( coefficient=0.711 , p=0.003 ) . 3 ) Before chemotherapy BMI values were positively related to PDGF levels ( rs=0.685 , p=0.029 ) , while after chemotherapy this relationship became non-significant ( rs=0.188 , p=0.603 ) . Before chemotherapy there was a negative relationship between VEGF and waist circumference ( coefficient= -0.542 , p=0.023 ) . CONCLUSIONS Post-glucose load insulin values significantly decrease after chemotherapy . There is a positive relationship between BMI and post-glucose load insulin before and after chemotherapy . The contribution of the reduction in insulin , a known growth factor , to the outcome of chemotherapy in these patients remains speculative at present Tamoxifen is a nonsteroidal anti-estrogenic drug used for adjuvant treatment of breast cancer and recently as a chemopreventative agent for breast cancer and , on an investigational basis , for other cancers . To date there are case reports of hypertriglyceridemia and fatty liver disease in tamoxifen users . Fatty liver is associated with visceral obesity and other components of the metabolic syndrome . Here we evaluated steatosis and adipose tissue distribution by CT scan in a cross-sectional study of 32 women on tamoxifen and 39 control women . Tamoxifen users had more visceral adipose tissue ( VAT ) and more liver fat than controls . This is the first study to demonstrate that fatty liver and intra-abdominal fat accumulation are common in breast cancer patients receiving tamoxifen . Prospect i ve studies of tamoxifen should monitor metabolic changes in obese women with or without breast cancer Introduction Research has been limited in circadian activity rhythms and their relationship with health status in early-stage breast cancer survivors . Maintaining strong circadian parameters may reduce symptoms and improve physical functioning and disease-free survival . Methods This is a descriptive , correlational , secondary analysis of data from a r and omized controlled trial collected 1 year after the first chemotherapy treatment ; n = 156 cases with 7 days of wrist actigraph data of six circadian activity rhythm parameters ; measures of function , fatigue , sleep , and anxiety/depression ; and demographic/medical data including body mass index ( BMI ) . Results In the total sample and three BMI categories , acrophase was the only circadian parameter that reached means established in healthy adults . In the total sample , phase-delayed acrophase was associated with higher depression ( r = 0.180 , p = 0.025 ) and lower morning energy ( r = −0.194 , p = 0.016 ) and trended for higher fatigue ( r = 0.153 , p = 0.057 ) . Lower morning energy was also associated with a lower circadian quotient ( r = 0.158 , p = 0.05 ) . As BMI increased , weaker circadian parameters were recorded consistently . When compared with women in normal BMI categories , obese women ’s amplitude and 24-h autocorrelation coefficient were significantly weaker ( p = 0.011–0.015 ) . In obese women , phase-delayed acrophase was correlated with higher fatigue and anxiety and with lower morning energy and physical functioning . Discussion / conclusions Amplitude and 24-h autocorrelation parameters were significantly weaker , and phase-delayed acrophase was linked to several more intense symptoms and lower physical functioning in obese women . Implication s for cancer survivorsClinicians need to target high-risk women with phase-delayed rhythms , higher symptoms , and lower physical functioning for intervention Obese breast cancer patients have a higher risk of lymph node metastasis and a poorer prognosis compared to patients with normal weight . For obese women with node-positive breast cancer , an association between body weight and prognosis remains unclear . In this retrospective study , we analyzed patient data from the Phase-III ADEBAR trial , in which high-risk breast cancer patients ( pT1–4 , pN2–3 , pM0 ) were r and omized into a docetaxel-based versus epirubicin-based chemotherapy regimen . Patients were grouped according to their BMI value as underweight/normal weight ( BMI < 25 kg/m2 ; n = 543 ) , overweight ( BMI 25–29.9 kg/m2 ; n = 482 ) or obese ( BMI ≥ 30 kg/m2 ; n = 285 ) . Overweight and obese patients were older , had larger tumors and were more likely to be postmenopausal at the time of diagnosis compared to underweight/normal-weight patients ( all p < 0.001 ) . Multivariate Cox regression analyses adjusting for age and histopathological tumor features showed that obese patients had a significantly shorter disease-free survival ( DFS ; HR 1.43 ; 95 % CI 1.11–1.86 ; p = 0.006 ) and overall survival ( OS ; HR 1.56 ; 95 % CI 1.14–2.14 ; p = 0.006 ) than non-obese patients . Subgroup analyses revealed that the differences in DFS and OS were significant for postmenopausal but not for premenopausal patients , and that the survival benefit of non-obese patients was more pronounced in women with hormone-receptor-positive disease . Obesity constitutes an independent , adverse prognostic factor in high-risk node-positive breast cancer patients , in particular for postmenopausal women and women with hormone-receptor-positive disease Certain food groups are often rejected during chemotherapy ( CT ) due to the side effects of treatment , which may interfere with adequate diet and nutritional status . The aim of this study was to evaluate the treatment impact on the diet and nutritional status of women with breast cancer ( BC ) . In this prospect i ve longitudinal study , conducted in 2014–2015 , 55 women diagnosed with BC , with a mean age 51.5±10.1 years , were followed and data were collected at three different times . Anthropometric and dietary assessment s were performed , the latter by applying nine 24h dietary recalls , by using the Brazilian Healthy Eating Index Revised ( BHEI-R ) , and calculating the prevalence of inadequacy by the EAR cut-off point method . Regarding the BHEI-R analysis , the majority of women had a “ diet requires modification ’ , both at the beginning ( T0 , 58.2 % , n = 32 ) and during treatment ( T1 , 54.5 % , n = 30 ) . However , after the end of the CT , the greater percentage of patients ( T2 , 49.1 % , n = 27 ) were classified as having an " inadequate diet " , since the Total Fruit consumption as well as the Dark Green and Orange Vegetable and Legume consumption decreased significantly during treatment ( p = 0.043 and p = 0.026 , respectively ) . There was a significant reduction in the intake of macro and micronutrients , with a high prevalence of inadequacy , of up to 100 % , for calcium , iron , phosphorus , magnesium , niacin , riboflavin , thiamin , vitamin B6 , vitamin C and zinc . Assessment of the nutritional status indicated that 56 % ( n = 31 ) of patients were overweight at these three different times . Weight , BMI and Waist Circumference increased significantly , indicating a worse nutritional status , and there was a correlation between poor diet quality and higher values for BMI , Waist-Hip Ratio and Waist-to-Height Ratio . Chemotherapy interferes in the patients ’ diet generating a negative impact on the quality and intake of micro and macronutrients , as well as an impact on their nutritional status , with an increase in anthropometric measurements Purpose Breast cancer treatments have been associated with an increased risk of multiple health-related adverse outcomes , but the relationship with diabetes remains unclear . This study investigated the association between hormone therapy and diabetes risk in breast cancer survivors . Patients and Methods We performed a case-cohort study of 2,246 female survivors recruited from the Leumit health care fund who were diagnosed with primary nonmetastatic invasive breast cancer in 2002 through 2012 . A 20 % r and om subcohort was sample d at baseline , and all diabetes cases were identified . Adjusted hazard ratios ( HRs ) with 95 % CIs were estimated by weighted Cox proportional hazards regression models . Results Of 2,246 breast cancer survivors , 324 developed diabetes over a mean follow-up of 5.9 years . The crude cumulative incidence of diabetes that accounted for death as a competing risk was 20.9 % ( 95 % CI , 18.3 % to 23.7 % ) . In multivariable-adjusted models , hormone therapy was associated with increased diabetes risk ( HR , 2.40 ; 95 % CI , 1.26 to 4.55 ; P = .008 ) . The hazard for tamoxifen use ( Output:	RESULTS A general trend of increased glucose and insulin is seen and likely to be caused by weight gain and /or changes in body composition as a consequence of adjuvant treatment of BC .
MS2611	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE The aim was to determine long-term mortality rates and the underlying cause of death for subjects with different peripheral arterial disease ( PAD ) stages in a population based setting . METHODS A r and omly selected population sample of 5080 subjects was enrolled in the study in 2004 - 2005 . Participants completed health state question naires and underwent ankle brachial index ( ABI ) measurements for classification into PAD severity stages and reference subjects . A follow-up was conducted by the end of 2015 using data from Swedish governmental national registers for cause of death , which was then compared with PAD stage determined at baseline in 2005 . RESULTS The 10 year all cause mortality was 27 % for reference cases , 56 % for asymptomatic PAD ( APAD ) , 63 % for intermittent claudication ( IC ) , and 75 % for severe limb ischaemia ( SLI ) . Among all PAD subjects , cardiovascular ( CV ) causes were the most common main cause of death ( 45 % ) and a CV event was present as either the main or one of the three most common contributing causes of death in 64 % of the cases . The age adjusted hazard ratios for a main cause of death by a CV event were 1.9 ( 95 % CI 1.5 - 2.3 ) for APAD , 2.6 ( 95 % CI 2.1 - 3.4 ) for IC , and 3.5 ( 95 % CI 2.3 - 5.2 ) for SLI . CONCLUSION PAD subjects , including the APAD subjects , are still at high risk of CV death . The mortality risks are more than doubled in symptomatic PAD patients compared with reference subjects and increase by severity of PAD stage . Awareness and improved risk reduction management of PAD are still warranted BACKGROUND Patients with lower extremity peripheral artery disease ( PAD ) are at increased risk of major adverse cardiovascular events ( MACE ) and major adverse limb events ( MALE ) . There is limited information on the prognosis of patients who experience MALE . OBJECTIVES Among participants with lower extremity PAD , this study investigated : 1 ) if hospitalizations , MACE , amputations , and deaths are higher after the first episode of MALE compared with patients with PAD who do not experience MALE ; and 2 ) the impact of treatment with low-dose rivaroxaban and aspirin compared with aspirin alone on the incidence of MALE , peripheral vascular interventions , and all peripheral vascular outcomes over a median follow-up of 21 months . METHODS We analyzed outcomes in 6,391 patients with lower extremity PAD who were enrolled in the COMPASS ( Cardiovascular Outcomes for People Using Anticoagulation Strategies ) trial . COMPASS was a r and omized , double-blind placebo-controlled study of low-dose rivaroxaban and aspirin combination or rivaroxaban alone compared with aspirin alone . MALE was defined as severe limb ischemia leading to an intervention or major vascular amputation . RESULTS A total of 128 patients experienced an incident of MALE . After MALE , the 1-year cumulative risk of a subsequent hospitalization was 61.5 % ; for vascular amputations , it was 20.5 % ; for death , it was 8.3 % ; and for MACE , it was 3.7 % . The MALE index event significantly increased the risk of experiencing subsequent hospitalizations ( hazard ratio [ HR ] : 7.21 ; p < 0.0001 ) , subsequent amputations ( HR : 197.5 ; p < 0.0001 ) , and death ( HR : 3.23 ; p < 0.001 ) . Compared with aspirin alone , the combination of rivaroxaban 2.5 mg twice daily and aspirin lowered the incidence of MALE by 43 % ( p = 0.01 ) , total vascular amputations by 58 % ( p = 0.01 ) , peripheral vascular interventions by 24 % ( p = 0.03 ) , and all peripheral vascular outcomes by 24 % ( p = 0.02 ) . CONCLUSIONS Among individuals with lower extremity PAD , the development of MALE is associated with a poor prognosis , making prevention of this condition of utmost importance . The combination of rivaroxaban 2.5 mg twice daily and aspirin significantly lowered the incidence of MALE and the related complications , and this combination should be considered as an important therapy for patients with PAD . ( Cardiovascular Outcomes for People Using Anticoagulation Strategies [ COMPASS ] ; NCT01776424 ) Principled methods with which to appropriately analyze missing data have long existed ; however , broad implementation of these methods remains challenging . In this and 2 companion papers ( Am J Epidemiol . 2018;187(3):576 - 584 and Am J Epidemiol . 2018;187(3):585 - 591 ) , we discuss issues pertaining to missing data in the epidemiologic literature . We provide details regarding missing- data mechanisms and nomenclature and encourage the conduct of principled analyses through a detailed comparison of multiple imputation and inverse probability weighting . Data from the Collaborative Perinatal Project , a multisite US study conducted from 1959 to 1974 , are used to create a masked data -analytical challenge with missing data induced by known mechanisms . We illustrate the deleterious effects of missing data with naive methods and show how principled methods can sometimes mitigate such effects . For example , when data were missing at r and om , naive methods showed a spurious protective effect of smoking on the risk of spontaneous abortion ( odds ratio ( OR ) = 0.43 , 95 % confidence interval ( CI ) : 0.19 , 0.93 ) , while implementation of principled methods multiple imputation ( OR = 1.30 , 95 % CI : 0.95 , 1.77 ) or augmented inverse probability weighting ( OR = 1.40 , 95 % CI : 1.00 , 1.97 ) provided estimates closer to the " true " full- data effect ( OR = 1.31 , 95 % CI : 1.05 , 1.64 ) . We call for greater acknowledgement of and attention to missing data and for the broad use of principled missing- data methods in epidemiologic research CONTEXT Among individuals with lower-extremity peripheral arterial disease ( PAD ) , specific leg symptoms and the ankle brachial index ( ABI ) are cross-sectionally related to the degree of functional impairment . However , relations between these clinical characteristics and objective ly measured functional decline are unknown . OBJECTIVE To define whether PAD , ABI , and specific leg symptoms predict functional decline at 2-year follow-up . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study among 676 consecutively identified individuals ( aged > or = 55 years ) with and without PAD ( n = 417 and n = 259 , respectively ) , with baseline functional assessment s occurring between October 1 , 1998 , and January 31 , 2000 , and follow-up assessment s scheduled 1 and 2 years thereafter . PAD was defined as ABI less than 0.90 , and participants with PAD were categorized at baseline into 1 of 5 mutually exclusive symptom groups . MAIN OUTCOME MEASURES Mean annual changes in 6-minute walk performance and in usual-paced and fast-paced 4-m walking velocity , adjusted for age , sex , race , prior-year functioning , comorbid diseases , body mass index , pack-years of cigarette smoking , and patterns of missing data . RESULTS Lower baseline ABI values were associated with greater mean ( 95 % confidence interval ) annual decline in 6-minute walk performance ( -73.0 [ -142 to -4.2 ] ft for ABI < 0.50 vs -58.8 [ -83.5 to -34.0 ] ft for ABI 0.50 to < 0.90 vs -12.6 [ -40.3 to 15.1 ] ft for ABI 0.90 - 1.50 , P = .02 ) . Compared with participants without PAD , PAD participants with leg pain on exertion and rest at baseline had greater mean annual decline in 6-minute walk performance ( -111 [ -173 to -50.0 ] ft vs -8.67 [ -36.9 to 19.5 ] ft , P = .004 ) , usual-pace 4-meter walking velocity ( -0.06 [ -0.09 to -0.02 ] m/sec vs -0.01 ( -0.03 to 0.003 ] m/sec , P = .02 ) , and fastest-pace 4-meter walking velocity ( -0.07 [ -0.11 to -0.03 ] m/sec vs -0.02 [ -0.04 to -0.006 ] m/sec , P = .046 ) . Compared with participants without PAD , asymptomatic PAD was associated with greater mean annual decline in 6-minute walk performance ( -76.8 ( -135 to -18.6 ] ft vs -8.67 ( -36.9 to 19.5 ] ft , P = .04 ) and an increased odds ratio for becoming unable to walk for 6 minutes continuously ( 3.63 ; 95 % confidence interval , 1.58 - 8.36 ; P = .002 ) . CONCLUSIONS Baseline ABI and the nature of leg symptoms predict the degree of functional decline at 2-year follow-up . Previously reported lack of worsening in claudication symptoms over time in patients with PAD may be more related to declining functional performance to than lack of disease progression OBJECTIVE To determine changes over time in the ankle brachial index ( ABI ) among subjects with and without intermittent claudication in the general population . DESIGN OF STUDY Population cohort study . SETTING General population in Edinburgh , Scotl and . SUBJECTS A total of 1592 men and women aged 55 to 74 years selected at r and om from age-sex registers of 11 general practice s and followed up over 12 years . Main outcome measures Changes in ABI for each leg recorded at baseline in 1988 and at subsequent 5-year and 12-year clinical examinations . RESULTS Overall , 695 subjects ( 348 men and 347 women ) had valid ABI measurements on both legs at all three examinations . At baseline , the ABI was on average.03 higher in the right leg than the left ( P < or = .001 ) . Men had a mean ABI that was.07 higher than women ( P < or = .001 ) . Mean ABI in the worse leg showed little change over 12 years in both men and women . However , in the whole population , the ABI in the better leg showed a significant drop , 1.15 to 1.08 ( P < or = .001 ) . A total of 179 cases of intermittent claudication were identified during the 12-year follow-up . At baseline , ABI in the worse leg of the claudicants was significantly lower than in healthy subjects ( .99 vs 1.08 ; P < or = .01 ) . In claudicants , mean ABI in the worse leg fell by.04 over 5 years ( P < or = .05 ) and in the better leg showed a highly significant drop of.09 ( P < or = .001 ) to levels similar to those of the worse leg . CONCLUSIONS The mean ABI in the worse leg of study subjects showed little progression over 12 years . Individuals with intermittent claudication experienced a greater decline in both legs compared with those without claudication . Deterioration occurred more rapidly in the limb with a higher ABI at baseline , which possibly indicates a systemic tendency to atherosclerosis Observational longitudinal research is particularly useful for assessing etiology and prognosis and for providing evidence for clinical decision making . However , there are no structured reporting requirements for studies of this design to assist authors , editors , and readers . The authors developed and tested a checklist of criteria related to threats to the internal and external validity of observational longitudinal studies . The checklist criteria concerned recruitment , data collection , biases , and data analysis and descriptive issues relevant to study rationale , study population , and generalizability . Two raters independently assessed 49 r and omly selected articles describing stroke research published from 1999 to 2003 in six journals : American Journal of Epidemiology , Journal of Epidemiology and Community Health , Stroke , Annals of Neurology , Archives of Physical Medicine and Rehabilitation , and American Journal of Physical Medicine and Rehabilitation . On average , 17 of the 33 checklist criteria were reported . Criteria describing the study design were better reported than those related to internal validity . No relation was found between study type ( etiologic or prognostic ) or word count and quality of reporting . A flow diagram for summarizing participant flow through a study was developed . Editors and authors should consider using a checklist and flow diagram when reporting on observational longitudinal research BACKGROUND The use of physical training in the treatment of intermittent claudication is well established . However , current data do not provide enough information about the prognosis for each case , and there are no data on how walking distances evolve over time with conservative treatment . The goal of this study was to evaluate improvement in walking capacity among patients with intermittent claudication who underwent unsupervised clinical treatment , observing whether sustained treatment would increase or decrease maximum walking distance , whether after 6 months there was a change in the maximum distance , and whether abstinence from smoking and well-conducted walking exercise Output:	Conclusions Progression of PAD in IC patients is probably underestimated in the literature due to study design issues . Predicting which patients with claudication are likely to deteriorate to critical limb ischaemia is difficult since there is a lack of evidence related to lower limb prognosis .
MS2612	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective The purpose of this r and omized study was to evaluate the influence of immediate multilayer compression b and ages before application of elastic stockings in the acute phase of deep-vein thrombosis ( DVT ) on development of the post-thrombotic syndrome ( PTS ) . Methods Sixty-nine patients with acute symptomatic DVT were r and omized to immediate b and aging ( n = 34 ) or no b and aging ( n = 35 ) . After reduction of edema sized-to-fit elastic stockings were applied in all patients after 7–14 days . Follow-up visits and non-invasive examinations were planned after 7 , 30 and 90 days and 1 year . Venous outflow resistance ( VOR ) was measured by strain gauge plethysmography . Thrombosis score ( TS ) and reflux were measured by duplex scanning . After one year patients were evaluated for clinical PTS using both the clinical scale of the CEAP classification and the Villalta score . Results Improvement of clinical symptoms and decrease of leg circumference was better on day 7 in the b and aging group , but after 1 and 3 months clinical symptoms had improved equally in both groups . In 7 patients in the no-b and aging group a b and age was applied after all because of persistent edema after 10 days . There were no differences in VOR , TS and reflux . Using the CEAP classification the incidence of PTS was 39 % in patients with b and ages and 42 % in patients without b and ages ( RR 0.91 , 95 % CI 0.50–1.66 ) . Using the Villalta score the incidence of PTS was resp . 29 and 33 % ( RR 0.87 , 95 % CI 0.41–1.8 ) . There was no difference in severity of PTS . Conclusion Immediate multilayer compression b and aging in the acute phase of DVT is effective in reducing edema and complaints in the first week , but has no effect on thrombus regression , valve incompetence and the development of clinical PTS after 1 year BACKGROUND Post-thrombotic syndrome varies from mild oedema to incapacitating swelling with pain and ulceration . We investigated the rate of post-thrombotic syndrome after a first episode of deep-vein thrombosis and assessed the preventive effect of direct application of a sized-to-fit grade d compression stocking . METHODS Patients with a first episode of venogram-proven proximal deep-vein thrombosis were r and omly assigned no stockings ( the control group ) or made-to-measure grade d compression elastic stockings for at least 2 years . Post-thrombotic syndrome was assessed with a st and ard scoring system that combined clinical characteristics and objective leg measurements . Patients were assessed every 3 months during the first 2 years , and every 6 months thereafter for at least 5 years . The cumulative incidence of mild-to-moderate post-thrombotic syndrome was the primary outcome measure . FINDINGS Of the 315 consecutive out patients considered for inclusion , 44 were excluded and 77 did not consent to take part . 194 patients were r and omly assigned compression stockings ( n = 96 ) or no stockings ( n = 98 ) . The median follow-up was 76 months ( range 60 - 96 ) in both groups . Mild-to-moderate post-thrombotic syndrome ( score > or = 3 plus one clinical sign ) occurred in 19 ( 20 % ) patients in the stocking group and in 46 ( 47 % ) control-group patients ( p < 0.001 ) . 11 ( 11 % ) patients in the stocking group developed severe post-thrombotic syndrome ( score > or = 4 ) , compared with 23 ( 23 % ) patients in the control group ( p < 0.001 ) . In both groups , most cases of post-thrombotic syndrome occurred within 24 months of the acute thrombotic event . INTERPRETATION About 60 % of patients with a first episode of proximal deep-vein thrombosis develop post-thrombotic syndrome within 2 years . A sized-to-fit compression stocking reduced this rate by about 50 % BACKGROUND Graduated elastic compression ( GEC ) stockings have been demonstrated to reduce the morbidity associated with post-thrombotic syndrome . The ideal length or compression strength required to achieve this is speculative and related to physician preference and patient compliance . The aim of this study was to evaluate the hemodynamic performance of four different stockings and determine the patient 's preference . METHODS Thirty-four consecutive patients ( 40 legs , 34 male ) with post-thrombotic syndrome were tested with four different stockings ( Mediven plus open toe , Bayreuth , Germany ) of their size in r and om order : class 1 ( 18 - 21 mm Hg ) and class II ( 23 - 32 mm Hg ) , below-knee ( BK ) and above-knee thigh-length ( AK ) . The median age , Venous Clinical Severity Score , Venous Segmental Disease Score , and Villalta scale were 62 years ( range , 31 - 81 years ) , 8 ( range , 1 - 21 ) , 5 ( range , 2 - 10 ) , and 10 ( range , 2 - 22 ) , respectively . The C of C0 - 6EsAs , d , pPr , o was C0 = 2 , C2 = 1 , C3 = 3 , C4a = 12 , C4b = 7 , C5 = 12 , C6 = 3 . Obstruction and reflux was observed on duplex in 47.5 % legs , with deep venous reflux alone in 45 % . Air plethysmography was used to measure the venous filling index ( VFI ) , venous volume , and time to fill 90 % of the venous volume . Direct pressure measurements were obtained while lying and st and ing using the PicoPress device ( Microlab Elettronica , Nicolò , Italy ) . The pressure sensor was placed underneath the test stocking 5 cm above and 2 cm posterior to the medial malleolus . At the end of the study session , patients stated their preferred stocking based on comfort . RESULTS The VFI , venous volume , and time to fill 90 % of the venous volume improved significantly with all types of stocking versus no compression . In class I , the VFI ( mL/s ) improved from a median of 4.9 ( range , 1.7 - 16.3 ) without compression to 3.7 ( range , 0 - 14 ) BK ( 24.5 % ) and 3.6 ( range , 0.6 - 14.5 ) AK ( 26.5 % ) . With class II , the corresponding improvement was to 4.0 ( range , 0.3 - 16.2 ) BK ( 18.8 % ) and 3.7 ( range , 0.5 - 14.2 ) AK ( 24.5 % ) . Median stocking pressure ( mm Hg ) as measured with the PicoPress in class I was 23 ( range , 12 - 33 ) lying and 27 ( range , 19 - 39 ) st and ing ( P < .0005 ) and in class II was 28 ( range , 21 - 40 ) lying and 32 ( range , 23 - 46 ) st and ing ( P < .0005 ) . There was a significant but weak correlation ( Spearman ) between stocking interface pressure measured directly with the PicoPress and the VFI improvement ( baseline VFI-compression VFI ) at r = .237 ; P = .005 . Twenty-one patients ( legs ) changed their preference of compression and 38 % of these ( 8/21 patients , 9/21 legs ) preferred an AK-GEC stocking . CONCLUSIONS Compression significantly improved all hemodynamic parameters on air plethysmography . However , the hemodynamic benefit did not significantly change with the class or length of stocking . These results support the liberal selection of a GEC stocking based on patient preference Although below-knee compression elastic stockings ( CES ) are effective for the prevention of the postthrombotic syndrome ( PTS ) , a substantial number of patients with deep venous thrombosis still develop PTS . In the present open-label , r and omized clinical trial , we compared thigh-length with below-knee CES for the prevention of PTS . A total of 267 patients with the first episode of proximal deep venous thrombosis were r and omized to wear either thigh-length or below-knee CES for 2 years . After 3 , 6 , 12 , 18 , 24 , and 36 months , they were assessed for PTS manifestations according to the Villalta scale . PTS developed in 44 ( 32.6 % ) of the 135 patients r and omized to thigh-length CES and in 47 ( 35.6 % ) of the 132 allocated to below-knee CES , for an adjusted hazard ratio of 0.93 ( 95 % confidence interval , 0.62 - 1.41 ) . Severe PTS developed in 3 patients in each group . CES-related side effects developed in 55 ( 40.7 % ) of the 135 patients allocated to thigh-length CES and in 36 ( 27.3 % ) of those r and omized to the below-knee group ( P = .017 ) , and led to premature discontinuation of their use in 29 ( 21.5 % ) and 18 ( 13.6 % ) patients , respectively . We conclude that thigh-length CES do not offer a better protection against PTS than below-knee CES and are less well tolerated Objective Post-thrombotic syndrome is a chronic complication of acute deep venous thrombosis in the lower extremity . The role of graduated compression stockings in the prevention of post-thrombotic syndrome has been studied with opinion being divided on the beneficial effects . We aim to answer this question with a r and omized controlled study that uses multiple scoring instruments to assess post-thrombotic syndrome . Methods Sixty-nine consecutive patients with acute deep venous thrombosis diagnosed by duplex ultrasonography were r and omized to treatment with graduated compression stockings or no graduated compression stockings . Venous Clinical Severity Score and Villalta-Pr and oni Score , commonly used scoring systems , were used to appraise post-thrombotic syndrome at 3 , 6 , 12 , 18 , and 24 months following diagnosis of deep venous thrombosis . In both scoring systems , the individual either had post-thrombotic syndrome or no post-thrombotic syndrome . Cumulative incidence was computed using Kaplan – Meier analysis . Relative risk was assessed for age , obesity , varicose veins , and iliofemoral deep venous thrombosis . Results As measured by both Villalta-Pr and oni Score and Venous Clinical Severity Score instruments , the graduated compression stockings group had a lower incidence of post-thrombotic syndrome compared to the control group , but only when one month was used as cut off time for the first diagnosis of post-thrombotic syndrome . When 6 or 12 months were used , there was no difference in the incidence of post-thrombotic syndrome between the two groups . The burden of post-thrombotic syndrome was significantly more when the Villalta-Pr and oni Score instrument ( ∼75 % ) was used as compared to the Venous Clinical Severity Score instrument ( ∼30 % ) at 24 months ’ follow-up . Obesity was the only statistically significant predictor for the development of post-thrombotic syndrome . Conclusion As assessed by both Villalta-Pr and oni Score and Venous Clinical Severity Score instruments , use of graduated compression stockings does not reduce the incidence of post-thrombotic syndrome . There is a significant difference in the incidence post-thrombotic syndrome as detected by Villalta-Pr and oni Score and Venous Clinical Severity Score instruments with incidence of post-thrombotic syndrome dependent on instrument and cut off time interval used to assess post-thrombotic syndrome . However , larger prospect i ve studies are required to confirm these differences Objective To study whether stopping elastic compression stockings ( ECS ) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis . Design Multicentre single blind non-inferiority r and omised controlled trial . Setting Outpatient clinics in eight teaching hospitals in the Netherl and s , including one university medical centre . Participants Patients compliant with compression therapy for 12 months after symptomatic , ultrasound proven proximal deep venous thrombosis of the leg . Interventions Continuation or cessation of ECS 12 months after deep venous thrombosis . Main outcome measures The primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis , as assessed by the st and ardised Villalta scale in an intention to treat analysis . The predefined non-inferiority margin was 10 % . The main secondary outcome was quality of life ( VEINES-QOL/Sym ) . Results 518 patients compliant with ECS and free of post-thrombotic syndrome were r and omised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year . In the stop-ECS group , 51 of 256 patients developed post-thrombotic syndrome , with an incidence of 19.9 % ( 95 % confidence interval 16 % to 24 % ) . In the continue-ECS group , 34 of 262 patients developed post-thrombotic syndrome ( incidence 13. Output:	There was very limited evidence available for adverse effects and quality of life ( QoL ) . There is very limited evidence for adverse effects , patient satisfaction , QoL , and compliance rates . There is low-certainty evidence favouring use of intermittent pneumatic compression devices compared to a control device for the treatment of severity owing to different measurements used by the studies reporting on this outcome and small studies of short duration . There is moderate-certainty evidence of improved QoL but possible increased adverse effects related to compression device use owing to small studies of short duration .
MS2613	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: STUDY DESIGN R and omized controlled trial with pretraining , posttraining , and follow-up repeated measures . OBJECTIVE To determine the effectiveness of a 4-week elastic resistance exercise program on balance in subjects with and without a history of sprained ankles . BACKGROUND Several research ers have suggested that improving balance may help alleviate the symptoms of functional ankle instability and reduce the rate of recurrent ankle sprains . METHODS AND MEASURES Forty subjects ( 20 males , 20 females ; 20 subjects with chronic ankle instability [ CAI ] , 20 healthy ) participated in the study . Ten subjects ( 5 males , 5 females ) from each CAI and healthy group were r and omly assigned to either the exercise or control group , result ing in a total of 4 groups . Total travel distance of the center of pressure , monitored using a force platform , was measured before training , after 4 weeks of training , and at a 4-week follow-up . RESULTS There were no interactions between gender , ankle sprain history , or training groups . Balance significantly improved in subjects with and without a history of ankle sprains following 4 weeks of elastic resistance exercises . Mean improvement in balance for the exercise group following training , reflected through a decrease in total travel distance , was -11.1 cm ( 95 % confidence interval : -14.0 to -8.2 cm ) . These improvements in balance were retained 4 weeks after training . CONCLUSIONS Balance was improved after 4 weeks of elastic resistance exercise in subjects with and without a history of lateral ankle sprains . Balance improvements persisted 4 weeks following the treatment cessation Background Ankle sprains are common injuries that often lead to functional ankle instability ( FAI ) , which is a pathology defined by sensations of instability at the ankle and recurrent ankle sprain injury . Poor postural stability has been associated with FAI , and sports medicine clinicians rehabilitate balance deficits to prevent ankle sprains . Subsensory electrical noise known as stochastic resonance ( SR ) stimulation has been used in conjunction with coordination training to improve dynamic postural instabilities associated with FAI . However , unlike static postural deficits , dynamic impairments have not been indicative of ankle sprain injury . Therefore , the purpose of this study was to examine the effects of coordination training with or without SR stimulation on static postural stability . Improving postural instabilities associated with FAI has implication s for increasing ankle joint stability and decreasing recurrent ankle sprains . Methods This study was conducted in a research laboratory . Thirty subjects with FAI were r and omly assigned to either a : 1 ) conventional coordination training group ( CCT ) ; 2 ) SR stimulation coordination training group ( SCT ) ; or 3 ) control group . Training groups performed coordination exercises for six weeks . The SCT group received SR stimulation during training , while the CCT group only performed coordination training . Single leg postural stability was measured after the completion of balance training . Static postural stability was quantified on a force plate using anterior/posterior ( A/P ) and medial/lateral ( M/L ) center-of-pressure velocity ( COPvel ) , M/L COP st and ard deviation ( COPsd ) , M/L COP maximum excursion ( COPmax ) , and COP area ( COParea ) . Results Treatment effects comparing posttest to pretest COP measures were highest for the SCT group . At posttest , the SCT group had reduced A/P COPvel ( 2.3 ± 0.4 cm/s vs. 2.7 ± 0.6 cm/s ) , M/L COPvel ( 2.6 ± 0.5 cm/s vs. 2.9 ± 0.5 cm/s ) , M/L COPsd ( 0.63 ± 0.12 cm vs. 0.73 ± 0.11 cm ) , M/L COPmax ( 1.76 ± 0.25 cm vs. 1.98 ± 0.25 cm ) , and COParea ( 0.13 ± 0.03 cm2 vs. 0.16 ± 0.04 cm2 ) than the pooled means of the CCT and control groups ( P < 0.05 ) . Conclusion Reduced values in COP measures indicated postural stability improvements . Thus , six weeks of coordination training with SR stimulation enhanced postural stability . Future research should examine the use of SR stimulation for decreasing recurrent ankle sprain injury in physically active individuals with FAI STUDY DESIGN Single-group repeated measures with 2 raters . OBJECTIVES To determine the interrater and intrarater reliability of water volumetry and the figure of eight method on subjects with ankle joint swelling . BACKGROUND Measurements of ankle swelling are commonly performed to determine the nature and stage of injury and to monitor progress made during rehabilitation . Water volumetry and the figure of eight method are 2 techniques used to measure ankle swelling . METHODS AND MEASURES Twenty-nine subjects with ankle swelling were measured by 2 raters with the hypothesis that both measurement techniques would be reliable . Each rater performed 3 measurements of the swollen ankle using both measurement techniques during a single test session . The order of the rater and of the measurement technique was r and omized , and the raters were blinded to each other 's measurements . RESULTS We found high interrater reliability for both the water volumetry ( ICC [ intraclass correlation coefficient ] = 0.99 ) and figure of eight methods ( ICC = 0.98 ) . Additionally , intrarater reliability was high for both raters using both methods ( ICCs = 0.98 - 0.99 ) . CONCLUSIONS Both methods are reliable measures of ankle swelling . The authors recommend the figure of eight method because of its ease of use , time efficiency , and cost effectiveness . However , water volumetry may be more appropriate when measuring diffuse lower-extremity swelling . Reliability of these 2 methods was established using subjects with foot or ankle pathology . Therefore , the results are applicable and generalizable to the clinical setting Exercises to improve joint proprioception and coordination of the functionally unstable ankle are advocated throughout the literature , yet there is little evidence that these exercise have any effect on proprioception and balance . The purpose of this study was to determine the effects of a 6-week coordination and balance training program on proprioception of subjects with functional ankle instability . Forty-five subjects ( age = 22.53 + /- 3.95 years , height = 172.04 + /- 10.0 cm , weight = 71.72 + /- 15.7 kg ) were r and omly placed into a control ( Group 1 ) , sham ( Group 2 ) , or experimental ( Group 3 ) group . The experimental group trained 3 days per week , 10 minutes each day , performing various balance and proprioception exercises . Postural sway and active and passive joint position sense were assessed . Analysis of variance for postural sway modified equilibrium score for anterior and posterior sway , as well as medial and lateral sway revealed significant four-way interactions . Tukey post hoc analyses revealed that Group 3 performed significantly better ( p < .05 ) than Group 1 and Group 2 on the posttests . There were no significant differences for joint position sense or postural sway index . Results suggest that balance and coordination training can improve some measures of postural sway . It is still unclear if joint position sense can be improved in the functionally unstable ankle STUDY DESIGN Prospect i ve , r and omized controlled trial . OBJECTIVE To examine the effects of a 4-week rehabilitation program for chronic ankle instability ( CAI ) on postural control and lower extremity function . BACKGROUND CAI is associated with residual symptoms , performance deficits , and reinjury . Managing CAI is challenging and more evidence is needed to guide effective treatment . METHODS AND MEASURES Subjects with unilateral CAI were r and omly assigned to the rehabilitation ( CAI-rehab , n=16 ) or control ( CAI-control , n=13 ) group . Subjects without CAI were assigned to a healthy group ( n=19 ) . Baseline testing included the ( 1 ) center of pressure velocity ( COPV ) , ( 2 ) star excursion balance test ( SEBT ) , and ( 3 ) Foot and Ankle Disability index ( FADI ) and FADI-Sports Subscale ( FADI-Sport ) . The CAI-rehab group completed 4 weeks of rehabilitation that addressed range of motion , strength , neuromuscular control , and functional tasks . After 4 weeks , all subjects were retested . Nonparametric analyses for group differences and between-group comparisons were performed . RESULTS Subjects with CAI demonstrated deficits in postural control and SEBT reach tasks of the involved limb compared to the uninvolved limb and reported functional deficits of the involved limb compared to healthy subjects . Following rehabilitation , the CAI-rehab group had greater SEBT reach improvements on the involved limb than the other groups and greater improvements in FADi and FADI-Sport scores . CONCLUSIONS These results demonstrate postural control and functional limitations exist in individuals with CAl . In addition , rehabilitation appears to improve these functional limitations . Finally , there is evidence to suggest the SEBT may be a good functional measure to monitor change after rehabilitation for CAI Objective To evaluate the effectiveness of an unsupervised proprioceptive training programme on recurrences of ankle sprain after usual care in athletes who had sustained an acute sports related injury to the lateral ankle ligament . Design R and omised controlled trial , with one year follow-up . Setting Primary care . Participants 522 athletes , aged 12 - 70 , who had sustained a lateral ankle sprain up to two months before inclusion ; 256 ( 120 female and 136 male ) in the intervention group ; 266 ( 128 female and 138 male ) in the control group . Intervention Both groups received treatment according to usual care . Athletes allocated to the intervention group additionally received an eight week home based proprioceptive training programme . Main outcome measure Self reported recurrence of ankle sprain . Results During the one year follow-up , 145 athletes reported a recurrent ankle sprain : 56 ( 22 % ) in the intervention group and 89 ( 33 % ) in the control group . Nine athletes needed to be treated to prevent one recurrence ( number needed to treat ) . The intervention programme was associated with a 35 % reduction in risk of recurrence . Cox regression analysis showed significantly fewer recurrent ankle sprains in the intervention than in the control group . This effect was found for self reported recurrent ankle sprains ( relative risk 0.63 , 95 % confidence interval 0.45 to 0.88 ) , recurrent ankle sprains leading to loss of sports time ( 0.53 , 0.32 to 0.88 ) , and recurrent ankle sprains result ing in healthcare costs or lost productivity costs ( 0.25 , 0.12 to 0.50 ) . No significant differences were found between medically treated athletes in the intervention group and medically treated controls . Athletes in the intervention group who were not medically treated had a significantly lower risk of recurrence than controls who were not medically treated . Conclusions The use of a proprioceptive training programme after usual care of an ankle sprain is effective for the prevention of self reported recurrences . This proprioceptive training was specifically beneficial in athletes whose original sprain was not medically treated . Trial registration Ankle sprains are often complicated by functional instability and repeated sprains . Rehabilitation with wobble boards in patients with functional instability has been tested , and significant improvement has been found compared to no training . The aim of this study was to investigate whether the number of patients with residual symptoms following ankle sprains could be reduced by training on a wobble board during 12-week recovery period . In addition , the influence of training in the time course reduction of edema was investigated . We performed a prospect i ve study including 61 patients , all active in sports for more than 2 hours a week with primary ankle sprains . The effect of a 12-week training program with wobble board was compared with no training . Forty-eight patients completed the study . In the follow-up period ( mean X = 230 days ) , we found significantly fewer recurrent sprains , and significantly fewer patients in the training group had functional instability of the ankle compared with the no training group . There were no differences in the two groups in the time which elapsed before patients were painless at walking , during running , or at sports . Volumetric measurements revealed no difference in the speed of reduction of hematoma and edema of the ankle and foot between the two groups . We conclude that training on a wobble board early after primary stage 2 ankle sprains is effective in reducing residual symptoms following this lesion and that training does not seem to affect the time course reduction in edema PURPOSE The aim of the present study was to investigate the effects of a 6-wk multi-station proprioceptive exercise program that is easy to integrate in normal training programs . METHODS Patients with chronic ankle instability were used , and results of three testing procedures before and afterward were compared : joint position sense , postural sway , and muscle reaction times to sudden inversion events on a tilting platform . A total of 30 subjects with 48 unstable feet were evaluated ( exercise group : N = 31 ; control group : N = 17 ) . RESULTS In the exercise group , the results showed a significant improvement in joint position sense and postural sway as well as significant changes in muscle reaction times . CONCLUSION Based on the present results , a multi-station proprioceptive exercise program can be recommended for prevention and rehabilitation of recurrent ankle inversion injuries Background : A search of the literature shows that the effect of surgery on ankle proprioception has been hardly investigated . Objective : To examine the effect of anatomical reconstruction of the anterolateral capsuloligamentous complex on ankle joint position sense . Methods : A prospect i ve study using the “ slope box ” test . Ten consecutive Output:	There was no consensus on the advantages of including proprioceptive training in the rehabilitation of this population for swelling , postural sway , joint position sense , ankle range of motion or return to sport outcomes .
MS2614	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Purpose Physicians sometimes make management recommendations on the basis of early results from r and omized controlled trials ( RCTs ) relating to reduced prostate-specific antigen ( PSA ) failure , yet whether this early end point is associated with all-cause mortality ( ACM ) , particularly in men with competing risks , is unknown . Using a vali date d metric in men treated within the context of an RCT , we aim ed to determine whether PSA failure is associated with the risk of ACM stratified by comorbidity score . Patients and Methods Between 1995 and 2001 , 206 men with localized ( T1b to 2b ) intermediate- and high-risk prostate cancer ( PC ) were r and omly assigned to receive radiation therapy or radiation therapy and 6 months of ADT . Cox regression analyses were performed to evaluate whether PSA failure modeled as a time-dependent covariate was associated with an increased risk of ACM among men with Adult Comorbidity Evaluation-27-defined no or minimal versus moderate-to-severe comorbidity adjusting for age , PC prognostic factors , and treatment . Results After a median follow-up of 16.62 years , 156 men ( 76 % ) died , 29 of whom ( 19 % ) died as a result of PC . PSA failure was associated with an increased ACM risk among men with no or minimal ( adjusted hazard ratio , 1.59 ; 95 % CI , 1.03 to 2.46 ; P = .04 ) , but not moderate or severe comorbidity ( adjusted hazard ratio , 1.75 ; 95 % CI , 0.76 to 3.99 ; P = .19 ) . Conclusion Recommending treatment on the basis of reduced PSA failure observed from early results of RCTs is unlikely to prolong survival in men with moderate-to-severe comorbidity but may prolong survival in men with no or minimal comorbidity , providing evidence to support discussing the early results with these men BACKGROUND The comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen ( PSA ) testing remains uncertain . METHODS We compared active monitoring , radical prostatectomy , and external-beam radiotherapy for the treatment of clinical ly localized prostate cancer . Between 1999 and 2009 , a total of 82,429 men 50 to 69 years of age received a PSA test ; 2664 received a diagnosis of localized prostate cancer , and 1643 agreed to undergo r and omization to active monitoring ( 545 men ) , surgery ( 553 ) , or radiotherapy ( 545 ) . The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up . Secondary outcomes included the rates of disease progression , metastases , and all-cause deaths . RESULTS There were 17 prostate-cancer-specific deaths overall : 8 in the active-monitoring group ( 1.5 deaths per 1000 person-years ; 95 % confidence interval [ CI ] , 0.7 to 3.0 ) , 5 in the surgery group ( 0.9 per 1000 person-years ; 95 % CI , 0.4 to 2.2 ) , and 4 in the radiotherapy group ( 0.7 per 1000 person-years ; 95 % CI , 0.3 to 2.0 ) ; the difference among the groups was not significant ( P=0.48 for the overall comparison ) . In addition , no significant difference was seen among the groups in the number of deaths from any cause ( 169 deaths overall ; P=0.87 for the comparison among the three groups ) . Metastases developed in more men in the active-monitoring group ( 33 men ; 6.3 events per 1000 person-years ; 95 % CI , 4.5 to 8.8 ) than in the surgery group ( 13 men ; 2.4 per 1000 person-years ; 95 % CI , 1.4 to 4.2 ) or the radiotherapy group ( 16 men ; 3.0 per 1000 person-years ; 95 % CI , 1.9 to 4.9 ) ( P=0.004 for the overall comparison ) . Higher rates of disease progression were seen in the active-monitoring group ( 112 men ; 22.9 events per 1000 person-years ; 95 % CI , 19.0 to 27.5 ) than in the surgery group ( 46 men ; 8.9 events per 1000 person-years ; 95 % CI , 6.7 to 11.9 ) or the radiotherapy group ( 46 men ; 9.0 events per 1000 person-years ; 95 % CI , 6.7 to 12.0 ) ( P<0.001 for the overall comparison ) . CONCLUSIONS At a median of 10 years , prostate-cancer-specific mortality was low irrespective of the treatment assigned , with no significant difference among treatments . Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring . ( Funded by the National Institute for Health Research ; ProtecT Current Controlled Trials number , IS RCT N20141297 ; Clinical Trials.gov number , NCT02044172 . ) PURPOSE We evaluated predictors of prostate cancer-specific mortality ( PCSM ) after prostate-specific antigen ( PSA ) failure after radical prostatectomy ( RP ) or radiation therapy ( RT ) . PATIENTS AND METHODS A total of 1,159 men with clinical ly localized prostate cancer treated with RP ( n = 498 ) or RT ( n = 661 ) developed PSA failure , and they formed the study cohort . Competing risk regression analyses were used to evaluate whether previously identified predictors of time to metastasis , including post-treatment PSA doubling time ( PSA-DT ) , Gleason score , and interval to PSA failure , could also predict time to PCSM after PSA failure . The cumulative incidence method was used to estimate PCSM after PSA failure . RESULTS A post-RP PSA-DT of less than 3 months ( hazard ratio [ HR ] , 54.9 ; 95 % CI , 16.7 to 180 ) , a post-RT PSA-DT of less than 3 months ( HR , 12.8 ; 95 % CI , 7.0 to 23.1 ) , and a biopsy Gleason score of 8 to 10 ( HR , 6.1 ; 95 % CI , 3.4 to 10.7 ) for patients treated with RT were significantly associated with PCSM . Post-RP estimated rates of PCSM 5 years after PSA failure were 31 % ( 95 % CI , 17 % to 45 % ) v 1 % ( 95 % CI , 0 % to 2 % ) for patients with PSA-DT of less than 3 months v > or = 3 months . Post-RT estimated rates of PCSM 5 years after PSA failure were 75 % ( 95 % CI , 59 % to 92 % ) v 35 % ( 95 % CI , 24 % to 47 % ) for patients with a biopsy Gleason score of > or = 8 v < or = 7 , respectively , and PSA-DT of less than 3 months ; these rates were 15 % ( 95 % CI , 0.8 % to 28 % ) v 4 % ( 95 % CI , 1 % to 6 % ) , respectively , for patients with a PSA-DT > or = 3 months . CONCLUSION Patients at high risk for PCSM after PSA failure can be identified based on post-RP PSA-DT or post-RT PSA-DT and biopsy Gleason score . These parameters may be useful in identifying patients for a r and omized trial evaluating hormonal therapy with or without docetaxel Background : The optimal management of men with PSA failure following initial prostate cancer ( PC ) therapy stratified by comorbidity is unknown . We investigated the impact that PSA doubling time ( DT ) and comorbidity had on the risk of all-cause mortality ( ACM ) , prostate cancer-specific mortality ( PCSM ) and other-cause mortality ( OCM ) following PSA failure . Methods : Between 1995 and 2001 , 206 men with unfavorable-risk PC were r and omized to receive radiation therapy alone or in combination with 6 months of and rogen deprivation therapy ( ADT ) ; 108 men experienced PSA failure and formed the study cohort . Cox and Fine – Gray regression analysis was used to determine whether PSA DT was associated with the risk of ACM and PCSM/OCM , respectively , stratified by comorbidity status using a vali date d metric . Results : After a median follow-up of 13.71 years following PSA failure , 81 of the 108 men ( 75 % ) died . Longer PSA DT was associated with a decreased risk of PCSM in men with no/minimal ( adjusted hazard ratio ( AHR ) 0.33 , 95 % confidence interval ( CI ) 0.17–0.65 , P=0.001 ) and moderate/severe comorbidity ( AHR 0.014 , 95 % CI 0.002–0.129 , P=0.0002 ) . However , because of the different contributions of the risk of OCM to risk of ACM within comorbidity subgroups , increasing PSA DT was only associated with a decreased risk of ACM in men with no/minimal ( AHR 0.69 , 95 % CI 0.50–0.96 , P=0.03 ) but not moderate/severe comorbidity ( AHR 0.95 , 95 % CI 0.51–1.78 , P=0.87 ) . Conclusions : Both the extent of comorbidity and the PSA DT should be taken into consideration when deciding on appropriate management and /or clinical trial eligibility at the time of PSA failure BACKGROUND Hormonal manipulation concomitant to salvage radiotherapy ( SRT ) given for biochemical recurrence ( BCR ) after radical prostatectomy ( RP ) improved outcomes in two r and omized trials . However , neither of these studies focused on men treated at low prostate-specific antigen ( PSA ) levels . OBJECTIVE To test if the impact of and rogen deprivation therapy ( ADT ) on metastasis in patients undergoing early SRT varies according to prostate cancer ( PCa ) features . DESIGN , SETTING , AND PARTICIPANTS A total of 525 patients received SRT at PSA levels ≤2ng/ml . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES Multivariable Cox regression analyses assessed factors associated with metastasis . We tested the hypothesis that the impact of ADT varied according to the risk of metastasis . An interaction with groups ( concomitant ADT vs no ADT ) and the probability of distant metastasis according to a newly developed model was tested . A nonparametric curve explored the relationship between the risk of metastasis and 10-yr metastasis rates according to ADT . RESULTS AND LIMITATIONS Median PSA and radiotherapy dose were 0.42ng/ml and 66Gy , respectively . Overall , 178 ( 34 % ) patients received ADT . At a median follow-up of 104 mo , 71 patients experienced metastasis . Grade group ≥4 ( hazard ratio [ HR ] : 1.66 ; 95 % confidence interval [ CI ] : 1.01 - 3.30 ) , pT3b/4 ( HR : 2.61 ; 95 % CI : 1.51 - 4.52 ) , and dose ( HR : 0.82 ; 95 % CI : 0.76 - 0.89 ) were associated with metastasis . The impact of ADT differed according to the risk of metastasis calculated using a multivariable model ( p=0.01 ) . This was confirmed when considering patients treated with early SRT ( p=0.046 ) , where ADT was associated with a reduction in the rate of metastasis only in eSRT ; patients with more aggressive characteristics ( ie , pT3b/4 and grade group ≥4 , or pT3b/4 and PSA at eSRT ≥0.4ng/ml ) . CONCLUSIONS The beneficial effect of ADT concomitant to eSRT varied significantly according to disease characteristics , such that only men with more aggressive PCa features benefit from ADT in the eSRT setting for BCR after RP . PATIENT SUMMARY The oncological benefits of concomitant and rogen deprivation therapy ( ADT ) in patients undergoing salvage radiotherapy ( SRT ) vary according to pathological characteristics . Only patients with more aggressive disease characteristics seemed to benefit from the use of hormonal manipulation at the time of early SRT . Conversely , the potential side effects of ADT could be spared in patients with low prostate-specific antigen levels and favorable pathological features BACKGROUND Patients with lymph node (LN)-positive prostate cancer ( PCa ) at radical prostatectomy ( RP ) face a high risk of cancer recurrence . Nevertheless , recurrence patterns of LN-positive PCa and their prognostic significance remain understudied in the literature . OBJECTIVE To analyze a large single-institution series with long-term follow-up to eluci date the various clinical recurrence patterns of LN-positive PCa and their association with oncologic outcomes . DESIGN , SETTING , AND PARTICIPANTS Years 1987 - 2012 Output:	BCR was associated with worse survival rates , mainly in patients with short prostate-specific antigen doubling time ( PSA-DT ) and a high final Gleason score after RP , or a short interval to biochemical failure ( IBF ) after RT and a high biopsy Gleason score . BCR has an impact on survival , but this effect appears to be limited to a subgroup of patients with specific clinical risk factors . Short PSA-DT and a high final Gleason score after RP , and a short IBF after RT and a high biopsy Gleason score are the main factors that have a negative impact on survival . For many men , rising PSA does not mean that they are at a high risk of death from prostate cancer in the longer term . Men with PSA that rises shortly after they were treated with radiotherapy or rapidly rising PSA after surgery and a high tumor grade for both treatment modalities are at the highest risk of death .
MS2615	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Previous studies have shown that the bisphosphonates ( BP ) vary in their damaging effect on the gastric mucosa , and endoscopy scores ( erosions or erosions plus ulcers ) after 1 and 2 weeks use of BP were significantly lower in H. pylori-positive versus -negative subjects . The mechanism of this damaging effect of BP and the interaction with H. pylori is unknown . As part of a separately reported study of the incidence of gastric damage after 2 weeks of treatment of healthy female postmenopausal volunteers with risedronate ( 5 mg/day ) or alendronate ( 10 mg/day ) , gastric aspirates were taken at the time of the baseline esophagogastroduodenoscopy ( EGD ) , and again at 1 and 2 weeks after daily intake of a BP . At the time of the third EGD , when the volunteers had been on risedronate or alendronate for 2 weeks , antral biopsies were taken from normal-appearing mucosa . Gastric juice and antral biopsies were assessed for their concentration of the cytokines interleukin-1α ( IL-1α ) , IL-8 , IL-13 , and epidermal growth factor ( EGF ) . H. pylori , the use of BP , and development of gastric mucosal lesions had no effect on gastric mucosal concentrations of IL-1α , IL-13 , or EGF . In contrast , the concentration of IL-8 in antral mucosal biopsies of volunteers given BP for 2 weeks was higher in the presence than in the absence of an H. pylori infection and was increased further in those who develop lesions associated with the use of BP . There was no correlation between gastric mucosal and gastric juice concentrations of IL-8 . Gastric juice concentrations of IL-8 and EGF were not affected by H. pylori status , the use of BP , or the development of lesions . However , gastric juice concentrations of IL-1α were numerically lower in those who were negative for H. pylori with no mucosal lesions ( Hp−L− ) , intermediate in those who were H. pylori-negative with lesions ( Hp−L+ ) , and highest in those who were positive for H. pylori and had lesions ( Hp+L+ ) . The gastric juice concentration of IL-13 was threefold higher in the absence than in the presence of H. pylori , and the relative abundance of IL-13 was : Hp−L− > Hp−L+ > Hp+L−1 > Hp+L+ . The prostagl and in E2 concentration in gastric antral biopsies was similar in the four groups and was unchanged with the in vitro biopsy incubation with celecoxib . We speculate that the higher gastric endoscopy scores observed with the use of BP in H. pylori negative as compared with H. pylori positive individuals is due to their lower mucosal concentration of IL-8 as well as the lower gastric juice concentration of IL-1α and higher concentration of IL-13 BACKGROUND This study characterized the phenotypic subsets of isolated gastric lymphocytes and the cellular immune response in cultured gastric biopsy specimens . METHODS Endoscopy specimens from 40 Helicobacter pylori-positive and 40 H. pylori-negative patients were studied . a ) Isolated gastric lymphocytes were analysed for CD4 + , CD8 + T-lymphocyte subsets , activated T cells , and natural killer cells on a fluorescence-activated cell sorter , using monoclonal antibodies . b ) The supernatant of cultured gastric biopsy specimens were assayed for interleukin (IL)-2 , IL-4 , and IL-6 levels . RESULTS In H. pylori-positive patients there was ( a ) a decrease in CD4+/CD8 + T cells , no change in activated T cells , and an increase in natural killer cells , and ( b ) no change in IL-2 levels and a significant increase in IL-4 and IL-6 levels . CONCLUSIONS There is an increase in CD8 + lymphocytes and natural killer cells , and the observed increase in IL-4 and IL-6 might be important in H. pylori-associated gastritis Objectives : In order to test the hypothesis that H. pylori infections in the gastric antrum increase pepsinogen I release , fasting serum pepsinogen I concentrations were compared in peptic ulcer patients with and without H. pylori infection . A r and omized prospect i ve study was performed to determine whether the increased serum pepsinogen I concentrations associated with H. pylori infection respond to treatment that eradicates H. pylori . Methods : Fasting serum pepsinogen I concentrations were measured by RIA in 736 patients with endoscopically and histologically confirmed benign peptic ulcer with and without H. pylori infection . Out of 511 patients with H. pylori infection , 110 patients ( group 1 ) were r and omly selected and were treated with metronidazole and tripotassium dicitrato bismuthate combined with ranitidine and antacid , and 97 patients ( group 2 ) were treated only with ranitidine and antacid . The third group , 54 patients free of H. pylori infection , was design ed to evaluate the influence of H2-receptor antagonist and antacid on the change of pepsinogen I. Fasting pepsinogen I concentration and H. pylori status were compared before and after the treatment . Results : Patients infected by H. pylori ( gastric ulcer 208 , duodenal ulcer 303 ; total 511 ) had significantly higher fasting serum pepsinogen I concentrations than H. pylori negative patients ( gastric ulcer 110 , duodenal ulcer 115 : total 225 ) . Mean pepsinogen I level of the former was 124.3±46.9 and that of the latter was 77.9±25.8 ng/ml . ( p<0.0001 ) The difference in serum pepsinogen I concentrations according to the location of ulcer crater was significant only in non-infected subjects e.g. , mean pepsinogen I level H. pylori-negative gastric ulcer was significantly lower than that of H. pylori-negative duodenal ulcer patients . H. pylori was eradicated in all the patients who had received antibacterial therapy for 4 weeks and serum pepsinogen I concentrations were significantly decreased from 129.8 + 43.0 to 82.4±24.0 ng/ml after eradication of the organism . ( p<0.0001 ) In contrast , H. pylori-positive patients who had not received antibacterial therapy were still infected at the completion of the study and there was no significant change in the serum pepsinogen I concentrations after the treatment ( 120.8±40.9 vs 126.3± 40.4 ng/ml ) . ( p>0.57 ) None of the patients who were initially H. pylori-negative has been reinfected during the period of the study and their serum pepsinogen I concentrations were not changed . ( pre-treatment value 75.1±8.0 ; post-treatment value 77.3±24.5 mg/ml)(p<0.75 ) Four-to six-week therapy of H2-receptor antagonist and antacid did not exert any influence on serum pepsinogen I concentrations . Conclusions : On the basis of our results , we have confirmed that the chronic infection of H. pylori of gastric antrum in peptic ulcer patients causes increased pepsinogen I release into the circulation , and eradication of the organism results in significant fall in serum pepsinogen I concentrations The aim of the present study was to determine the efficacy of a new combination regimen including antioxidant , proton pump inhibitor , and antibiotics against Helicobacter pylori and to document the changes of oxidative stress and cytokines involved in H. pylori-associated gastritis . From each of 57 patients with endoscopically diagnosed gastric and /or duodenal ulcers associated with H. pylori infection , five gastric antral biopsy specimens were taken for the diagnosis of H. pylori and for experimental measures . The patients were then treated either with lansoprozole 30 mg + amoxicillin 1.5 g ( LA group ; 21 patients ) or lansoprazole 30 mg + amoxicillin 1.5 g + rebamipide 300 mg ( LAM group ; 36 patients ) for two weeks . Four weeks after the initiation of treatment , the patients were endoscoped again and biopsy specimens were obtained . Mucosal malondialdehyde ( MDA ) levels ; myeloperoxidase ( MPO ) activities ; superoxide dismutase ; catalase ; glutathione peroxidase ; cytokines IL-1 , IL-6 , TNF-alpha ; and chemokines IL-8 , GRO-alpha , RANTES ( regulated on activation normal T expressed and secreted ) were measured . Using paraffin-embedded tissue sections , in situ terminal deoxyribonucleotide transferase ( TdT ) -mediated dUTP nick end labeling ( TUNEL ) for apoptosis and immunohistochemical staining for inducible nitric oxide synthase ( iNOS ) were performed . Two weeks of treatment with the LA regimen result ed in 57.4 % eradication rates of H. pylori , whereas two weeks of treatment with the LAM regimen result ed in 75.0 % eradication rates . Eradication rates between these two groups were statistically significantly different ( P < 0.05 ) . Mucosal MDA levels and MPO activities were significantly lower in the LAM group than the LA group . Mucosal levels of cytokines IL-1 , IL-6 , and TNF-alpha and of chemokines IL-8 , GRO-alpha , and RANTES were all significantly decreased after the treatment of H. pylori , especially in the LAM-treated group . The apoptotic index and iNOS score were significantly reduced after the eradication of H. pylori . The addition of the antioxidative drug rebamipide to the eradication regimen against H. pylori has quantitative and qualitative advantages such as either augmenting the eradication rates of H. pylori or decreasing oxidative stress and cytokines levels generated by H. pylori infection Helicobacter pylori ( H pylori ) raises serum gastrin but it is unclear whether this stimulates increased acid secretion . Gastrin mediated acid secretion and plasma gastrin after the intravenous infusion of gastrin releasing peptide was studied in nine H pylori negative and nine H pylori positive healthy volunteers , and in 11 duodenal ulcer patients . Nine of the last group were re-examined one month after eradication of H pylori . The median acid output ( mmol/h ) to gastrin releasing peptide ( 40 pmol/kg/h ) in the H pylori positive healthy volunteers was 15.1 ( range 3.3 - 38.3 ) , which was three times that of the H pylori negative healthy volunteers ( median = 5.5 , range 1.0 - 9.0 ) ( p < 0.02 ) . The median acid output in the duodenal ulcer patients with H pylori was 37 ( range 8.5 - 57 ) , which was > six times that of the H pylori negative healthy volunteers . Eradication of H pylori in the duodenal ulcer patients lowered their acid secretion by a median of 66 % ( range 30%-80 % ) ( p < 0.01 ) and to values equivalent to the H pylori positive healthy volunteers . The pepsin output in response to gastrin releasing peptide followed the same pattern as the acid output . The median plasma gastrin concentrations during gastrin releasing peptide were similar in the H pylori positive duodenal ulcer patients ( 150 ng/l , range 95 - 400 ) and H pylori positive healthy volunteers ( 129 ng/l , range 23 - 420 ) and both were appreciably higher than H pylori negative healthy volunteers ( 60 ng/l , range 28 - 135 ) ( p < 0.005 for each ) . Eradication of H pylori lowered the plasma gastrin in the duodenal ulcer patients to values equivalent to the H pylori negative healthy volunteers . These findings show a threefold increase in acid secretion in H pylori positive healthy volunteers that is explained by H pylori induced hypergastrinaemia and a sixfold increase in acid secretion in the duodenal ulcer patients that is explained by the combination of H pylori induced hypergastrinaemia and an exaggerated acid response to stimulation by gastrin . Eradicating H pylori lowers gastrin mediated acid secretion by 66 % in duodenal ulcer patients as a result of the resolution of the hypergastrinaemia . Increased gastrin mediated acid secretion seems to be the key factor in the pathophysiology of duodenal ulceration and explains the role of H pylori infection in the disorder Ascorbic acid , the reduced form of vitamin C , may protect against gastric cancer and is secreted by the normal stomach . Secretion is impaired in Helicobacter pylori ( H pylori ) associated chronic gastritis . This study examined if eradication of H pylori improves gastric juice ascorbate values . Fasting gastric juice and Output:	Results : In addition to st and ard markers such as pepsinogens , we confirmed the close relationship between the levels of several biomarkers including gastrin , interleukin-8 , HLA class II molecules , reactive oxygen species , and the histological grade s. Conclusions : This review provides valuable information describing the clinical implication of these biomarkers for evaluating the static conditions or dynamic alterations of human gastric inflammation
MS2616	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Hypertension is a complex chronic condition characterized by elevated arterial blood pressure . Management of hypertension includes non-pharmacologic strategies , which may include techniques that effectively reduce autonomic sympathetic activity . Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex . Because of these effects , respiratory exercises may be useful to lower blood pressure in subjects with hypertension . Methods / design This r and omized , double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension . Subjects are r and omly allocated to intervention or control groups . Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure , readjusted weekly . Control sham intervention consists of unloaded exercises . Systolic and diastolic blood pressures are co- primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring . Secondary outcome measures include cardiovascular autonomic control , inspiratory muscle metaboreflex , cardiopulmonary capacity , and inspiratory muscle strength and endurance . Discussion Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension , but the effectiveness of this intervention is yet to be established . We propose an adequately sized r and omized clinical trial to test this hypothesis rigorously . If an effect is found , this study will allow for the investigation of putative mechanisms to mediate this effect , including autonomic cardiovascular control and metaboreflex . Trial registration Clinical Trials.gov NCT02275377 . Registered on 30 September 2014 Objective : To evaluate heart rate variability during an inspiratory muscle endurance protocol at three different load levels [ 30 % , 60 % and 80 % of maximal inspiratory pressure ] , in patients who had previously undergone coronary artery bypass grafting . Methods : Nineteen late postoperative myocardial revascularization patients participating in a cardiovascular rehabilitation program were studied . Maximal inspiratory pressure maneuvers were performed . An inspiratory muscle endurance protocol at 30 % , 60 % and 80 % of maximal inspiratory pressure was applied for four minutes each , in r and om order . Heart rate and RR intervals were recorded and heart rate variability was analyzed by time ( RMSSD-the mean of the st and ard deviations for all R-R intervals , and RMSM-root-mean square differences of successive R-R intervals ) and frequency domains indices ( high and low frequency ) in normalized units . ANOVA for repeated measurements was used to compare heart rate variability indices and Student t-test was used to compare the maximal inspiratory pressure and maximal expiratory pressure values . Results : Heart rate increased during performance of maximal respiratory pressures maneuvers , and the maximal inspiratory pressure and maximal expiratory pressure mean values were significantly lower than predicted values ( P<0.05 ) . RMSSD increased significantly at 80 % in relation to rest and 30 % of maximal inspiratory pressure and RMSM decreased at 30 % and 60 % of maximal inspiratory pressure in relation to rest ( P<0.05 ) . Additionally , there was significant and progressive decrease in low frequency and increase in high frequency at 30 % , 60 % and 80 % of maximal inspiratory pressure in relation to the resting condition . Conclusion : These results suggest that respiratory muscle training at high intensities can promote greater parasympathetic activity and it may confer important benefits during a rehabilitation program in post-coronary artery bypass grafting Introduction Cardiac surgery is a highly complex procedure which generates worsening of lung function and decreased inspiratory muscle strength . The inspiratory muscle training becomes effective for muscle strengthening and can improve functional capacity . Objective To investigate the effect of inspiratory muscle training on functional capacity submaximal and inspiratory muscle strength in patients undergoing cardiac surgery . Methods This is a clinical r and omized controlled trial with patients undergoing cardiac surgery at Instituto Nobre de Cardiologia . Patients were divided into two groups : control group and training . Preoperatively , were assessed the maximum inspiratory pressure and the distance covered in a 6-minute walk test . From the third postoperative day , the control group was managed according to the routine of the unit while the training group underwent daily protocol of respiratory muscle training until the day of discharge . Results 50 patients , 27 ( 54 % ) males were included , with a mean age of 56.7±13.9 years . After the analysis , the training group had significant increase in maximum inspiratory pressure ( 69.5±14.9 vs. 83.1±19.1 cmH2O , P=0.0073 ) and 6-minute walk test ( 422.4±102.8 vs. 502.4±112.8 m , P=0.0031 ) . Conclusion We conclude that inspiratory muscle training was effective in improving functional capacity submaximal and inspiratory muscle strength in this sample of patients undergoing cardiac surgery Background Physical exercise reduces glucose levels and glucose variability in patients with type 2 diabetes . Acute inspiratory muscle exercise has been shown to reduce these parameters in a small group of patients with type 2 diabetes , but these results have yet to be confirmed in a well- design ed study . The aim of this study is to investigate the effect of acute inspiratory muscle exercise on glucose levels , glucose variability , and cardiovascular autonomic function in patients with type 2 diabetes . Methods / design This study will use a r and omized clinical trial crossover design . A total of 14 subjects will be recruited and r and omly allocated to two groups to perform acute inspiratory muscle loading at 2 % of maximal inspiratory pressure ( PImax , placebo load ) or 60 % of PImax ( experimental load ) . Discussion Inspiratory muscle training could be a novel exercise modality to be used to decrease glucose levels and glucose variability . Trial registration Clinical Trials.gov NCT02292810 BACKGROUND The cardiovascular system is noticeably affected by respiration . However , whether different inspiratory resistive loading intensities can influence autonomic heart rate ( HR ) modulation remains unclear . OBJECTIVE The objective was to investigate HR modulation at three different inspiratory resistive loading intensities in healthy elderly men . METHOD This was a prospect i ve , r and omized , double-blind study that evaluated 25 healthy elderly men . Cardiac autonomic modulation was assessed using heart rate variability ( HRV ) indices . All of the volunteers underwent maximal inspiratory pressure ( MIP ) measurements according to st and ardized pulmonary function measurements . Three r and omly-applied inspiratory resistive loading ( 30 , 60 and 80 % of MIP ) intensities were then applied using an inspiratory resistance device ( POWERbreathe , Southam , UK ) , during which the volunteers were asked to inhale for 2 seconds and exhale for 3 seconds and complete 12 breaths per minute . Each effort level was performed for 4 minutes , and HR and the distance between 2 subsequent R waves of electrocardiogram ( R-R intervals ) were collected at rest and at each intensity for further HRV analysis . RESULTS The parasympathetic HRV ( rMSSD , SD1 and HF ) indices demonstrated lower values at 80 % ( rMSSD : 19±2 ms , SD1 : 13±2 ms and HF : 228±61 ms2 ) than at 30 % MIP ( rMSSD : 25±3 ms , SD1 : 18±2 ms and HF : 447±95 ms2 ; p<0.05 ) . CONCLUSIONS Lower inspiratory resistive loading intensities promoted a marked and positive improvement of parasympathetic sinus node modulation The crural diaphragm ( CD ) is an essential component of the esophagogastric junction ( EGJ ) , and inspiratory exercises may modify its function . This study 's goal is to verify if inspiratory muscle training ( IMT ) improves EGJ motility and gastroesophageal reflux ( GER ) . Twelve GER disease [ GERD ; 7 males , 20 - 47 yr , 9 esophagitis , and 3 nonerosive reflex disease ( NERD ) ] and 7 healthy volunteers ( 3 males , 20 - 41 yr ) performed esophageal pH monitoring , manometry , and heart rate variability ( HRV ) studies . A 6-cm sleeve catheter measured average EGJ pressure during resting , peak inspiratory EGJ pressures during sinus arrhythmia maneuver ( SAM ) and inhalations under 17- , 35- , and 70-cmH2O loads ( TH maneuvers ) , and along 1 h after a meal . GERD patients entered a 5-days-a-week IMT program . One author scored heartburn and regurgitation before and after IMT . IMT increased average EGJ pressure ( 19.7 ± 2.4 vs. 29.5 ± 2.1 mmHg ; P < 0.001 ) and inspiratory EGJ pressure during SAM ( 89.6 ± 7.6 vs. 125.6 ± 13.3 mmHg ; P = 0.001 ) and during TH maneuvers . The EGJ-pressure gain across 35- and 70-cmH2O loads was lower for GERD volunteers . The number and cumulative duration of the transient lower esophageal sphincter relaxations decreased after IMT . Proximal progression of GER decreased after IMT but not the distal acid exposure . Low-frequency power increased after IMT and the higher its increment the lower the increment of supine acid exposure . IMT decreased heartburn and regurgitation scores . In conclusion , IMT improved EGJ pressure , reduced GER proximal progression , and reduced GERD symptoms . Some GERD patients have a CD failure , and IMT may prove beneficial as a GERD add-on treatment OBJECTIVES This study sought to evaluate the effects of inspiratory muscle training in inspiratory muscle strength , as well as in functional capacity , ventilatory responses to exercise , recovery oxygen uptake kinetics , and quality of life in patients with chronic heart failure ( CHF ) and inspiratory muscle weakness . BACKGROUND Patients with CHF may have reduced strength and endurance in inspiratory muscles , which may contribute to exercise intolerance and is associated with a poor prognosis . METHODS Thirty-two patients with CHF and weakness of inspiratory muscles ( maximal inspiratory pressure [ Pi(max ) ] < 70 % of predicted ) were r and omly assigned to a 12-week program of inspiratory muscle training ( IMT , 16 patients ) or to a placebo-inspiratory muscle training ( P-IMT , 16 patients ) . The following measures were obtained before and after the program : Pi(max ) at rest and 10 min after maximal exercise ; peak oxygen uptake , circulatory power , ventilatory oscillations , and oxygen kinetics during early recovery ( VO2/t-slope ) ; 6-min walk test ; and quality of life scores . RESULTS The IMT result ed in a 115 % increment Pi(max ) , 17 % increase in peak oxygen uptake , and 19 % increase in the 6-min walk distance . Likewise , circulatory power increased and ventilatory oscillations were reduced . The VO2/t-slope was improved during the recovery period , and quality of life scores improved . CONCLUSIONS In patients with CHF and inspiratory muscle weakness , IMT results in marked improvement in inspiratory muscle strength , as well as improvement in functional capacity , ventilatory response to exercise , recovery oxygen uptake kinetics , and quality of life Autonomic dysfunction , including baroreceptor attenuation and sympathetic activation , has been reported in patients with myocardial infa rct ion ( MI ) and has been associated with increased mortality . We tested the hypotheses that exercise training ( ET ) in post-MI patients would normalize arterial baroreflex sensitivity ( BRS ) and muscle sympathetic nerve activity ( MSNA ) , and long-term ET would maintain the benefits in BRS and MSNA . Twenty-eight patients after 1 month of uncomplicated MI were r and omly assigned to 2 groups , ET ( MI-ET ) and untrained . A normal control group was also studied . ET consisted of three 60-minute exercise sessions per week for 6 months . We evaluated MSNA ( microneurography ) , blood pressure ( automatic oscillometric method ) , heart rate ( ECG ) , and spectral analysis of RR interval , systolic arterial pressure ( SAP ) , and MSNA . Baroreflex gain of SAP-RR interval and SAP-MSNA were calculated using the & agr;-index . At 3 to 5 days and 1 month after MI , MSNA and low-frequency SAP were significantly higher and BRS significantly lower in MI patients when compared with the normal control group . ET significantly decreased MSNA ( bursts per 100 heartbeats ) and the low-frequency component of SAP and significantly increased the low-frequency component of MSNA and BRS of the RR interval and MSNA . These changes were so marked that the differences between patients with MI and the normal control group were no longer observed after ET . MSNA and BRS in the MI-untrained group did not change from baseline over the same time period . ET normalizes BRS , low-frequency SAP , and MSNA in patients with MI . These improvements in autonomic control are maintained by long-term ET . These findings highlight the clinical importance of this nonpharmacological therapy based on ET in the long-term treatment of patients with MI PURPOSE Patients with type 2 diabetes mellitus may present weakness of the inspiratory muscles . We tested the hypothesis that inspiratory muscle training ( IMT ) could improve inspiratory muscle strength , pulmonary function , functional capacity , and autonomic modulation in patients with type 2 diabetes and weakness of the inspiratory muscles . M Output:	The results demonstrated that IMT performed at low intensities can chronically promote an increase in the parasympathetic modulation and /or reduction of sympathetic cardiac modulation in patients with diabetes , hypertension , chronic heart failure and gastroesophageal reflux , when assessed by HRV spectral analysis .
MS2617	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A single blind trial and a placebo controlled double blind trial of lithium were carried out in elderly patients with tardive dyskinesia . In the pilot study , neuroleptics were continued : in the controlled trial , neuroleptics were discontinued . The results of both studies were essentially negative . Thus , the suppression effect of neuroleptics is much more dramatic than anything seen in the two studies . Several reasons for this were discussed namely , the severity and chronicity of the symptoms Eleven patients with tardive dyskinesia were treated with lithium carbonate in a placebo-controlled double-blind crossover study . No significant effect of lithium on either tardive dyskinesia or blood prolactin concentrations was demonstrated , but 5 patients developed pseudo-Parkinsonian features Psychiatric in patients with tardive dyskinesia ( TD ) were treated with either lithium alone ( n = 9 ) or with a combination of lithium and lecithin ( n = 9 ) for 5 weeks in a double-blind , placebo-controlled experiment . A statistically significant but clinical ly unimportant improvement of TD occurred during both treatments . The addition of lecithin to lithium had no effect The effectiveness of a once-weekly i.m . injection of ceruletide ( 0.8 microgram/kg ) in suppressing the symptoms of neuroleptic-induced tardive dyskinesia ( TD ) was evaluated in a double-blind , placebo-controlled , matched-pairs study . Global evaluation of the severity of TD symptoms over the 8-week study period revealed a significant improvement with ceruletide as compared with placebo . Analysis of the therapeutic response to ceruletide over the course of treatment revealed a slow , but long-lasting improvement of TD symptoms . Side effects , which were mild and transient , consisted mainly of nausea and epigastric discomfort . The incidence of side effects did not differ between the ceruletide- and placebo-treated groups . Ceruletide appears to be a novel and practical treatment that can substantially alleviate the symptoms of dyskinesia The beneficial effect of estrogens on L -dopa-induced dyskinesias and on tardive dyskinesia has recently been reported . In this open pilot study , conjugated estrogens ( CE ) were Eight psychiatric patients with tardive dyskinesia ( TD ) were treated with single doses of the synthetic met-enkephalin analogue FK 33 - 824 ( 1 , 2 , and 3 mg IM ) morphine ( 10 mg SC ) and naloxone , an opiate receptor antagonist ( 0.8 mg IM ) . The drug effects were assessed by blind evaluation of r and omly sequenced videotapes made before and during treatment . FK 33 - 824 ( 1,2 , and 3 mg IM ) slightly reduced TD ( P<0.05 ) and increased preexisting bradykinesia . The effect on TD , however , was pronounced only in patients concurrently treated with neuroleptics in relatively high doses . Morphine had a similar although weaker antihyperkinetic effect , whereas naloxone had no effect . Side effects of FK 33 - 824 included dizziness , heaviness in the extremities , slurred speech , and dryness of mouth . Morphine caused drowsiness , dizziness , ataxia , and nausea , and naloxone had no side effects . The results do not point to a primary role of enkephalin in the pathophysiology of TD , but enkephalin may interact with dopamine functions and potentiate some of the effects of neuroleptic drugs The unique role of ganglioside GM1 in neuronal plasticity led two centers , New York University and McLean Hospital , to study the effect of GM1 or placebo in patients with tardive dyskinesia . Results from the NYU cohort have already been published . We now present data from the entire cohort , allowing us to evaluate the effects of GM1 in the elderly compared to young adults . Subjects with tardive dyskinesia were r and omly assigned to single-blind placebo injections for 1 week , followed by 1 month of double-blind intramuscular placebo or GM1100 mg . The final sample included 29 patients : 12 younger than 55 years of age and 17 older . There was no GM1-versus-placebo difference observed in either-age group , or in the total group . However , whether on placebo or GM1 , repeated measures analysis of variance ( RANOVA ) found a significant difference in response between Abnormal Involuntary Movement Scale scores , taken baseline and week 4 , in the elderly compared to young adults . Scores for the young adults show initial improvement then deterioration back to baseline , and those for the elderly show continuing improvement during the 4-week trial . The importance of the placebo effect in the elderly and its meaning for studies of GM1 in tardive dyskinesia are discussed OBJECTIVE The study investigated the efficacy and tolerability of ethyl-eicosapentaenoic acid ( E-EPA ) as add-on treatment in chronic , severe schizophrenia . METHOD A r and omized , parallel-group , double-blind , placebo-controlled , fixed-dose , add-on study was conducted over 12 weeks . Forty patients with persistent symptoms after at least 6 months of stable antipsychotic treatment received E-EPA or placebo , in addition to their existing treatment . RESULTS At 12 weeks , the E-EPA group had significantly greater reduction of Positive and Negative Syndrome Scale total scores and of dyskinesia scores than the placebo group . CONCLUSIONS EPA may be an effective and well-tolerated add-on treatment in schizophrenia The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas Estrogen have been reported in animal studies to both enhance and block central dopaminergic activity and in one clinical report to improve tardive dyskinesia . In the present study estrogen ( Premarin , 2.5 mg per day ) administration caused varying degrees of improvement in less than one-third of 21 patients with chorea due to Huntington 's disease and tradive dyskinesia and had no effect in eight patients with dystonia . Estrogens appear to have an antidopaminergic effect in humans but poses only limited efficacy in the treatment of dyskinetic disorders In an attempt to determine the role of serotoninergic mechanisms in the pathophysiology of tardive dyskinesia , the serotonin precursor 5-hydroxytryptophan ( 5HTP ) with carbidopa , a peripheral decarboxylase inhibitor , were given in a double-blind crossover design to seven patients with longst and ing tardive dyskinesia . In the five patients who completed the study , there was no change in dyskinetic movements . Most of the patients had worsening of psychotic symptoms with 5HTP . The data suggest that serotonin precursors have no therapeutic effects in tardive dyskinesia . The implication s for the role of serotonin in the pathophysiology of tardive dyskinesia are discussed Tardive dyskinesia ( TD ) is thought to result from nigrostriatal dopaminergic supersensitivity secondary to prolonged neuroleptic exposure . Pre clinical studies have demonstrated that the opiate antagonist naloxone can acutely reverse a haloperidol-induced hyperdopaminergic state . In a trial of high-dose naloxone , 20 patients with TD received i.v . naloxone ( 20 mg , 40 mg , and placebo ) under double-blind conditions . At baseline and at regular postdrug intervals , patients were evaluated using a battery of motor , clinical , and neuropsychological measures to study effects on neurological , behavioral , and cognitive functions . There was a significant improvement in involuntary movements at 30 min postnaloxone , together with improvement in clinical ratings at that time point , as well as some cognitive changes . The implication s of these findings for the putative functional relationship between dopaminergic and enkephalinergic systems in the nigrostriatal area are discussed Pre clinical and clinical observations suggest that enhancement of prostagl and in activity inhibits catecholamine release and may have antidyskinetic effects . A double-blind therapeutic trial with prostagl and in precursor essential fatty acids was conducted in 16 patients with tardive dyskinesia . No beneficial effects were seen The subjects were 13 psychiatric in patients with tardive dyskinesia . Each subject participated in two sessions . Either naloxone ( 10 mg ) or placebo was administered intravenously during each session . In a subset of subjects ( n = 7 ) , blood sample s for beta-endorphin were drawn before and at 30 and 60 minutes after the injection . The Abnormal Involuntary Movement Scale was administered before and at 10 , 20 , 40 , 60 , 120 , and 360 minutes after the injection . Double-blind procedures were maintained throughout the experiment . Neither naloxone nor placebo had any appreciable effect on the involuntary movements . Naloxone elicited a significant increase in the plasma beta-endorphin Tardive dyskinesia ( TD ) induced by antipsychotic drugs represents a great concern for patients and psychiatrists . Considering its pathophysiological mechanisms , there exists a convergence towards the development of postsynaptic dopaminergic hypersensitivity as a possible cause of TD . Hypersensitivity following receptor blockade is the consequence of an increased number of receptors and such a synthesis is energy-dependent . In the brain , under normal conditions , energy is almost exclusively provided by glucose utilization . We thus hypothesized that , if glucose availability were reduced , the metabolically hyperactive structures should represent the best functional target of a reduction in fuel availability . Twenty chronic schizophrenic out patients ( 13 males , 7 females ) , aged 20 - 67 ( mean : 38.3 ) , accepted to participate in this double-blind , placebo-controlled study . They were r and omly assigned to either the insulin treatment group ( 10 patients ) or to the insulin-placebo group ( 10 patients ) . They received a subcutaneous injection of 10 units of st and ard insulin or placebo at 10 a.m. From day 1 to day 15 , injections were performed daily and , thereafter , every other week for 5 weeks totalizing 20 injections in 90 days . At day 7 , the insulin treatment group showed a sharp decrease in the intensity of TD symptoms which persisted throughout the duration of the study . By contrast , no change in TD symptomatology was observed in the insulin-placebo-treated group . Although a direct effect on DA neurones , or at least the participation of such an effect , can not be excluded , our data favor a role of decreased glucose availability in reversing receptor hypersensitivity Despite continued research , the influences that promote or exacerbate tardive dyskinesia ( TD ) symptoms remain incompletely understood . Recent findings ( Gardos et al. 1992 ; Richardson et al. 1989 ) suggest that ingestion of the dietary constituent , phenylalanine , might exacerbate TD symptoms , but a double-blind , placebo-controlled challenge had not previously been conducted in schizophrenic patients . On two different mornings , in counterbalanced order , 18 male schizophrenic patients with TD were challenged with either 100 mg/kg phenylalanine or placebo . Effects on abnormal involuntary movements , recall memory , and plasma phenylalanine were measured 90 minutes post-challenge . The results supported the hypothesis in that involuntary movements increased to a statistically and clinical ly meaningful degree after the phenylalanine challenge , but not after placebo . No effects on memory were detected . Significant order effects characterized the plasma findings but not the behavioral data . Results indicate that a dietary constituent , the amino acid phenylalanine , can potentially exacerbate tardive dyskinesia symptoms in schizophrenic patients . The influence of phenylalanine and other ingested substances on clinical symptomatology warrants further investigation A double-blind r and omized clinical trial was conducted among 10 post-menopausal women with tardive dyskinesia ( TD ) to test the effect of estrogen replacement of the severity of abnormal movements and other outcome variables . After 3 weeks of treatment , the mean Abnormal Involuntary Movement Scale ( AIMS ) score decreased by 38 % in the estrogen group and by 9 % in the placebo group ; the difference between groups was marginally significant ( p less than 0.10 ) . However , the small sample size and the imbalance between groups in baseline AIMS scores do not allow us to rule out the confounding effects of other pro Output:	REVIEW ER 'S CONCLUSIONS There is no strong evidence to support the everyday use of any of the agents included in this review .
MS2618	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Malnutrition hastens progression to Acquired Human Immunodeficiency Syndromes ( AIDS ) related illnesses ; undermines adherence and response to antiretroviral therapy ( ART ) in re source -poor setting s. However , nutritional status of people living with HIV ( PLHIV ) can be affected by various psychosocial factors which have not been well explored in Ethiopia . Therefore , the objective of this study was to determine psychosocial correlates of nutritional status among people living with HIV ( PLHIV ) on ART in Central zone of Tigray , Northern Ethiopia . Methods A matched case-control study design was conducted to assess psychosocial correlates of nutritional status among PLHIV on ART . Data were collected by an interviewer-administered technique using structured pre-tested question naire , record review using a checklist and anthropometric measurements . Cases were selected by simple r and om sampling and controls purposively to match the selected cases . Conditional logistic regression was used to compute relevant associations by STATA version 12 . Results The psychosocial factors independently associated with malnutrition were ever consuming alcohol after starting ART [ AOR = 4.7 , 95 % CI : 1.8–12.3 ] , ever smoking cigarette after starting ART [ AOR = 7.6 , 95 % CI : 2.3–25.5 ] , depression [ AOR = 2.8 , 95 % CI : 1.3 , 6.1 ] , not adhering to ART [ AOR = 6.8,95 % CI : 2.0–23.0 ] and being in the second lowest wealth quintile [ AOR = 4.3,95 % CI : 1.1–17.7 ] . Conclusion Ever consuming alcohol and ever smoking cigarette after starting ART , depression , not adhering to ART and being in the second lowest wealth quintile were significantly associated with malnutrition . Therefore ; policies , strategies , and programs targeting people living with HIV should consider psychosocial factors that can impact nutritional status of people living with HIV enrolled on ART Background The devastating impact of AIDS in the world especially in sub-Saharan Africa has led to an unprecedented global effort to ensure access to antiretroviral ( ARV ) drugs . Given that medication-taking behavior can immensely affect an individual 's response ; ART adherence is now widely recognized as an ' Achilles heel ' for the successful outcome . The present study was undertaken to investigate the rate and predictors of adherence to antiretroviral therapy among HIV-infected persons in southwest Ethiopia . Methods The study was conducted in the antiretroviral therapy unit of Jimma University Specialized Hospital . A prospect i ve study was undertaken on a total of 400 HIV infected person . Data were collected using a pre-tested interviewer-administered structured question naire at first month ( M0 ) and third month ( M3 ) follow up visits . Results A total of 400 and 383 patients at baseline ( M0 ) and at follow up visit ( M3 ) respectively were interviewed . Self-reported dose adherence in the study area was 94.3 % . The rate considering the combined indicator ( dose , time and food ) was 75.7 % . Within a three month follow up period , dose adherence decreased by 2 % and overall adherence rate decreased by more than 3 % . Adherence was common in those patients who have a social support ( OR , 1.82 , 95%CI , 1.04 , 3.21 ) . Patients who were not depressed were two times more likely to be adherent than those who were depressed ( OR , 2.13 , 95%CI , 1.18 , 3.81 ) . However , at the follow up visit , social support ( OR , 2.42 , 95%CI , 1.29 , 4.55 ) and the use of memory aids ( OR , 3.29 , 95%CI , 1.44 , 7.51 ) were found to be independent predictors of adherence . The principal reasons reported for skipping doses in this study were simply forgetting , feeling sick or ill , being busy and running out of medication in more than 75 % of the cases . Conclusion The self reported adherence rate was high in the study area . The study showed that adherence is a dynamic process which changes overtime and can not reliably be predicted by a few patient characteristics that are assumed to vary with time . Adherence is a process , not a single event , and adherence support should be integrated into regular clinical follow up Health-related quality of life ( HRQoL ) is an important outcome measure among HIV-infected patients receiving combination antiretroviral therapy ( cART ) , but has not been studied extensively in re source -limited setting s. Insight in the predictors or correlates of poor HRQoL may be helpful to identify patients most in need of additional support and to design appropriate interventions . A cross-sectional study was conducted between September 2012 and April 2013 in 10 healthcare facilities in Addis Ababa , Ethiopia . Patients who were at least 6 months on cART were r and omly selected and individual patient data were retrieved from medical records . HRQoL was measured by the WHOQoL-HIVBREF , depressive-symptoms by the Kessler-6 scale , and stigma by the Kalichman internalized AIDS-related stigma scale . Multivariate linear regression analysis was carried-out to examine associations between HRQoL and the other variables . A total of 664 patients ( response-rate 95 % ) participated in the study . A higher level of depressive-symptoms was most strongly and consistently associated with a lower HRQoL , both in terms of the magnitude of the relationship and in the number of HRQoL domains associated with it . Also , a higher level of HIV-stigma was associated with a lower HRQoL except for the physical domain , while obtaining sufficient nutritious food and job opportunity were associated with a better HRQoL except for the spiritual and social domains , respectively . Demographics , clinical , and treatment characteristics yielded few significant associations with HRQoL. Our study findings suggest that interventions to improve HRQoL should focus on reducing depressive-symptoms and HIV-stigma , and on enhancing food security and job opportunity ABSTRACT Developing appropriate strategies to sustain optimal medication adherence among the increasing number of HIV-positive patients taking antiretroviral therapy ( ART ) in sub-Saharan Africa is a major challenge . The objective of this study was to determine patient , regimen , disease , patient-provider , and healthcare-related factors associated with adherence with ART over a one-year period , and assess the impact of adherence on treatment outcomes . We performed a prospect i ve , observational study among 246 patients who were initiated on ART in Ethiopia . Of 172 who completed follow-up , 130 ( 75.6 % ) had ≥95 % adherence . In the multivariate analyses , a higher baseline BMI ( OR , 1.2 ; 95 % CI 1.0 , 1.4 ) and use of reminder devices ( OR , 9.1 ; 95 % CI 2.0 , 41.6 ) remained positively associated with adherence , while a higher HIV symptom and adverse drug reaction distress score was an independent negative predictor of adherence ( OR , 0.90 ; 95 % CI 0.9 , 1.0 ) CD4 count increase was significantly higher in the adherent patients compared to non-adherent patients at 12 months ( 159 cells/µL [ interquartile range ( IQR ) , 72–324 cells/µL ] vs. 132 cells/µL [ IQR , 43–190 cells/µL ] ; p = 0.026 ) . Our findings indicate that interventions aim ed at improving adherence and thereby treatment outcomes in patients initiated on ART should promote the use of reminder devices , and monitor HIV symptoms and adverse reaction distress and nutritional status Output:	Conclusions and Recommendation The pooled estimate prevalence of depression among PLWHIV was higher than that in the general population . It is better to offer special attention to these population
MS2619	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This is an interim report of a r and omized clinical trial on esophagojeju-nostomy ( EJ ) versus Hunt-Lawrence-Rodino ( HLR ) pouch as reconstruction techniques following total gastrectomy and systematic lymphadenectomy for gastric cancer treatment . The r and omized trial preceded a pilot study comparing the Longmire-Gütgemann interposition and the HLR . The pilot study included 7 patients , the r and omized trial 38 patients ( 60 planned ) . The main outcome variables in the pilot study were food resorption , caloric intake , and body weight . Survival probability and general well-being ( quality of life ) were measured in the r and omized trial . A score was composed of disease-specific and socio-personal variables with well-being ranging from 0 ( worst ) to 14 ( best ) points . Concerning food resorption in the pilot study , no relevant advantage of the duodenal passage was found . The main postoperative disorder was insufficient food intake . Despite a radical operation , a hospital mortality rate of 16 % , and a complication rate of 37 % , gastric cancer still has a poor prognosis . In the r and omized trial only 15 ( 39 % ) of 38 patients were alive 1 year after operation , but the survival probability was higher ( 58 % ) after HLR than after EJ ( 24 % ) ( p<0.05 ) . Hunger and appetite were strongly reduced during the first 6 months after operation . Food intake was less than half of the preoperative values , which was reflected by an average decrease in body weight of 7 kg . Patients dying within the first year after total gastrectomy suffered an irreversible loss of quality of life ( scoring 7 points ) . They had no objective benefit from the operation . Patients surviving this period regained quality of life and exceeded preoperative values , especially after HLR.We conclude that HLR-operated patients who have a chance of surviving for at least 1 year benefit from total gastrectomy in regard to quality of life . RésuméCet article est consacré au bilan provisoire d'une étude clinique r and omisée de l'oesophago-jéjunostomie ( EJ ) par rapport à l'opération de Hunt-Lawrence-Rodino ( HLR ) comme technique de reconstruction après gastrectomie totale et lymphadénectomie systématique pour cancer de l'estomac . Le bilan a été établi à partir d'une étude pilote comparant l'interposition Longmire-Gütgemann et la HLR . Cette première étude a porté sur 7 patients et le étude r and omisée sur 38 patients ( 60 sont prévues ) . Dans l'étude pilote la réabsorption intestinale , le poids et l'absorption calorique furent les variables essentielles pour mesurer l'avenir des malades . Dans le étude r and omisée la probabilité de survie et la qualité de la vie ont été ajoutées . L'état général a été représenté par un score comprenant des variables spécifiques de la maladie et socio-personnelles allant de 0 ( très mal ) à 14 ( très bien ) points . Dans l'étude pilote le passage duodénal n'a pas montré d'avantage concernant la réabsorption intestinale . Le malaise post-opératoire essentiel a été l'insuffisance de l'absorption calorique . L'opération radicale a une mortalité hospitalière de 16 % et comprend un taux de complication de 37 % . Le cancer de l'estomac est de prognostic peu favorable . Seuls 15 ( 39 % ) des 38 patients ont survécu la première année dans le étude r and omisée mais la probabilité de survie après HLR ( 58 % ) dépasse celle après EJ ( 24 % ) ( p<0.05 ) . La f aim et l'appétit ont été sévèrement réduits pendant les 6 premiers mois post-opératoires . Comparée à la situation pré-opératoire , la quantitié de nourriture a diminué d'au moins 50 % ce qui correspond à une perte de poids de 7 kilos en moyenne . Les malades qui ne survivent pas la première année subissent une perte importante et irréversible de leur qualité de vie . Ceci nous amène à dire qu'ils ne profitent pas de l'intervention chirurgicale contraitement aux autres qui regagnent une qualité de vie égale ou même supérieure aux valeurs pré-opératoires . Au total nous pouvons affirmer que ce sont essentiellement les patients opérés qui ont subi une HLR qui survivent un an ou plus et qui tirent profit de la gastrectomie totale . ResumenEste es un informe provisional de un ensayo clínico aleatorizado para comparar la esofagoyeyunostomía ( EY ) con la bolsa de Hunt-Lawrence-Rodino ( HLR ) como técnicas de reconstrucción gástrica después de gastrectomía total con linfadenectomía sistemática como tratamiento del cáncer gástrico . El ensayo aleatorizado fue precedido de un estudio piloto para comparar el procedimiento de interposición de Longmire-Gütgemann con la HLR . El estudio piloto incluyó 7 pacientes y el ensayo aleatorizado 38 pacientes ( 60 fueron planeados ) . Las principales variables analizadas en el estudio piloto fueron la resorción de alimentos , la ingesta calórica , y el peso corporal . En el ensayo aleatorizado fueron analizadas , además , la probabilidad de supervivencia y el estado de bienestar general ( calidad de la vida ) . Se construyó un puntaje a partir de variables específicas de la enfermedad y sociopersonales para calificar el estado de bienestar general ( calidad de la vida ) entre 0 ( peor ) y 14 (óptimo).En el estudio piloto el paso a través del duodeno no demostró ventaja significativa en cuanto a la resorción intestinal . La principal alteración postoperatoria fue la ingesta alimenticia insuficiente . A pesar de una operación radical , una mortalidad de 16 % , y una tasa de complicaciones de 37 % , el cáncer gástrico mantiene un pronóstico poco favorable . En el ensayo aleatorizado sólo 15 ( 39 % ) de 38 pacientes sobrevivían 1 año después de la operación , con una probabilidad de supervivencia mayor ( 58 % ) después de la HLR que después de la EY ( 24 % ) ( p<0.05 ) . El hambre y el apetito aparecieron notoriamente disminuidos durante el primer semestre después de la operación . La ingesta de alimento fue menos de la mitad del valor preoperatorio , lo cual se manifestó en una disminución del peso corporal de 7 kg en promedio . Los pacientes que murieron en el curso del primer año después de la gastrectomía total exhibieron una disminución importante e irreversible de la calidad de la vida ( cerca de 7 puntos ) y no demostraron beneficio objetivo de la operación , en comparación con los que sobrevivieron tal período , quienes recuperaron una buena calidad de la vida con valores iguales o superiores a los preoperatorios , especialmente después de HLR.Nuestra conclusión es que los pacientes sometidos al procedimiento HLR que sobreviven por lo menos 1 año , se benefician de la gastrectomía total en lo relativo a la calidad de la vida Background The double tract ( DT ) method was compared with the Roux-en-Y ( R-Y ) method to identify the optimal reconstruction procedure after total gastrectomy for patients with gastric cancer . The DT reconstruction is as simple as the R-Y , and it can be safely performed even after total gastrectomy . However , these have been no studies evaluating the usefulness of DT reconstruction in comparison to R-Y reconstruction . Methods A group of 44 patients with gastric cancer were intraoperatively r and omized for R-Y ( n = 23 ) or DT reconstruction ( n = 21 ) after total gastrectomy ( TG ) . Body weight , food intake , nutritional conditions , and quality of life ( QOL ) were determined at 3 and 12 months after the operation . This study is registered with Clinical Trials.gov , no. NCT00746161 . Results Food intake significantly decreased soon after the operation . No differences were observed between the DT and R-Y groups . The body weight decreased throughout the ensuing period ( P < 0.05 ) and thereafter gradually recovered . However , no differences were observed between the two groups . Among the nutritional laboratory parameters , serum prealbumin , retinol-binding protein , total cholesterol , and triglyceride were decreased soon after the operation . The changes of those parameters were not substantially different between the two groups . The postoperative QOL was evaluated , and no differences were observed between those groups . Conclusions There were no particular advantages in the DT method after TG in comparison to the simple R-Y method in terms of body weight , QOL , and nutritional conditions , suggesting that the DT method might not be recommended after TG for patients with gastric cancer Out of 74 consecutive patients with gastric carcinoma only 39 patients fulfilled the inclusion criteria for this r and omized study . These patients were divided into two groups intraoperatively , 21 were reconstructed with and 18 without performing a stapled interposed jejunal pouch . Quality of life was evaluated using Spitzer 's QL index and Cuschieri 's assessment for 6 months . Spitzer 's QL index showed -- as expected -- no differences concerning the specific reconstruction in gastrointestinal complaints , whereas Cuschieri 's assessment revealed an advantage in the pouch group . Cuschieri 's assessment needs to be vali date d by larger comparable groups to prove its suitability for the determination of specific gastrointestinal complaints concerning the type of reconstruction in gastric cancer patients BACKGROUND Although more than 50 methods of gastric replacement after total gastrectomy have been used , none of them has demonstrated a substantial nutritional advantage . The Roux-en-Y esophagojejunostomy is still the preferred type of reconstruction , more because of its simplicity than the lack of postpr and ial disturbances . STUDY DESIGN A r and omized controlled trial was conducted to compare two reconstructive procedures , Roux-en-Y esophagojejunostomy ( n = 24 ) and Hunt-Rodino-Lawrence pouch ( HRL , n = 24 ) , by evaluating nutritional status ( body weight , arm circumference , and serum nutritional parameters ) , nutritional habits ( number of meals , energy intake , and postpr and ial disturbances ) , and emptying time of the jejunal loop . RESULTS Twenty-seven patients were studied two years after operation ( 12 had undergone Roux-en-Y and 15 had undergone HRL ) . No difference was found in either postoperative morbidity or mortality , emptying time , frequency of meals , or variation of body weight . Postpr and ial disturbances were more frequent in patients having Roux-en-Y. In a subset of patients , there was a correlation between nutrient intake and change of body weight , but not between nutrient intake and type of reconstruction . CONCLUSIONS The simple use of a reservoir such as the HRL pouch after total gastrectomy is of no benefit to the patient as compared with the Roux-en-Y reconstruction Patients with carcinoma of the stomach who underwent curative resection were r and omized to total gastrectomy ( n = 49 ) , total gastrectomy and an S‐shaped gastric substitute ( n = 28 ) or subtotal gastrectomy ( n = 12 ) ; all had a Roux‐en‐Y reconstruction . The gastric substitute and gastric remnant allowed a volume of 400–500 ml to be installed without increments in basal pressures . The corresponding volume in the Roux limb was 100 ml . Energy intake was approximately 120 kJ/kg preoperative weight per day 3 months after operation , and then remained constant . Patients who had subtotal gastrectomy ate less ( 91.7 kJ/kg preoperative weight ) 3 months after operation , but thereafter increased their intake . Patients allocated to have a gastric pouch or subtotal gastrectomy complained more frequently of adverse postpr and ial symptoms ( P < 0.03 ) as a major cause of reduced calorie intake . The construction of a gastric reservoir did not improve nutritional adaptation after surgery for gastric carcinoma Controversial results have been reported regarding the importance of the duodenal food passage after total gastrectomy . There are a number of experimental and clinical studies showing an advantage for the jejunal interposition between esophagus and duodenum . Others favor the Roux-en-Y reconstruction , as it is technically less dem and ing . The purpose of this study was the r and omized comparison between two major reconstruction principles after total gastrectomy for gastric cancer ( i.e. , jejunal interposition with pouch versus Roux-en-Y pouch reconstruction ) . A group of 120 patients with gastric cancer were r and omized and operated on during a 5-year period according to st and ardized operative protocol s , using either a jejunal interposition with pouch ( JIP ) or the Roux-en-Y reconstruction with pouch ( RYP ) . Endpoints of this study were operation time , intra- and postoperative problems and complications , patients ' body weight , functional assessment , and quality of life . Of the 120 patients , 14 had to be withdrawn during the operation because only the Roux-en-Y reconstruction was technically possible . Finally , 53 patients with JIP were compared with 53 patients with RYP for the perioperative course . There were no significant differences between the two procedures ( Output:	The results of the meta-analyses showed that operative mortality and morbidity were not significantly different between the two procedures ( preservation vs. non-preservation of duodenum ) . However , operative time was considerably prolonged by preserving the duodenal passage . Patients in the preservation group had an improved nutritional parameters ( body weight , levels of serum iron and hemoglobin ) in the short term ( < 6 months ) after surgery . Beneficial effect on preventing postgastrectomy symptom ( heartburn , dumping syndrome ) was not found by maintaining the duodenal passage throughout a 2-year follow-up . Moreover , a qualitative measurement showed that no significant quality of life improvement for patients with a preserved duodenal passage . Conclusion This systematic review failed to demonstrate obvious advantage in preserving duodenal passage after total gastrectomy
MS2620	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background There is little information on the validity of using record linkage with routinely collected data for case ascertainment of stroke in large population -based studies in the UK . We examined the accuracy of these routine record linkage approaches for identifying incident stroke cases in a large UK population -based study , the European Prospect i ve Investigation into Cancer (EPIC)-Norfolk cohort . Methods We examined a sample of hospital records of incident stroke cases identified by linkage with two routine data sources , death certificates and a national hospital record linkage system ( ENCORE ) , using predefined study criteria . Two senior Specialist Registrars with clinical experience in stroke medicine examined the hospital records and search ed for the evidence of stroke recorded in these records between 1993/97–2003 . Results Of 520 incident strokes identified between 1993/1997–2003 using record linkage systems in the EPIC-Norfolk , a sample of 250 medical case notes were examined between March and July 2004 . Using the predefined study criteria , there were 191 definite strokes ( 76 % ) , 20 probable strokes ( 8 % ) , 11 possible strokes and 11 cases of transient ischaemic attacks ( 4 % each ) i.e. 233/250 ( 93 % ) with possible or definite stroke or transient ischaemic attacks . Stroke could not be verified using hospital records in 13 cases ( 5 % ) and 4 cases ( 2 % ) had other diagnoses : 3 cases of vascular dementia and 1 case of benign intracranial hypertension . The diagnosis of stroke in 185 out of 250 cases identified in the EPIC-Norfolk ( 74.0 % ) was supported by radiological evidence using WHO criteria . Conclusion Death certificates and hospital record linkage in this British prospect i ve study have a high accuracy or positive predictive value in correctly identifying incident stroke cases BACKGROUND AND PURPOSE The Greater Cincinnati/Northern Kentucky Stroke Study was design ed to be the first large , population -based metropolitan study of temporal trends in stroke incidence rates and outcome within a biracial population . METHODS We are identifying all hospitalized and autopsied cases of stroke and transient ischemic attack ( TIA ) among the 1.3 million inhabitants of a five-county region of Greater Cincinnati/Northern Kentucky for the period 7/1/93 - 6/30/94 . We have already prospect ively monitored for out-of-hospital stroke and TIAs for this same time period at 128 screening sites , including a r and om sample of all primary care physicians and nursing homes in the region . We have already identified all hospitalized and autopsied cases of stroke and TIA among blacks for 1/1/93 - 6/30/93 and report preliminary incidence rates for this 6-month period . RESULTS The overall incidence rate for all first-ever hospitalized or autopsied stroke ( excluding TIAs ) among blacks in the Greater Cincinnati region was 288 per 100000 ( 95 % CI , 250 to 325 , age- and sex-adjusted to 1990 US population ) . The overall incidence rate for first-ever and recurrent stroke ( excluding TIAs ) was 411 per 100000 ( 95 % CI , 366 to 456 ) . By comparison , the overall incidence rate of first-ever stroke among whites in Rochester , Minn , during the period 1985 - 1989 was 179 per 100000 ( 95 % CI , 164 to 194 , age- and -sex adjusted to 1990 US population ) . The incidence rates among blacks in Greater Cincinnati were substantially greater than the rates among whites in Rochester , Minn , for all age categories except ages 75 and older , for which the rates were similar . CONCLUSIONS We conservatively estimate that 731100 first-ever or recurrent strokes occurred in the United States during 1996 . Studies of first-ever as well as total stroke among biracial and representative population s are critical for underst and ing temporal trends in the incidence rate and the burden of stroke in the US population Background and Purpose — Many studies use medical record review for ascertaining outcomes . One large , longitudinal study , the Women ’s Health Initiative ( WHI ) , ascertains strokes using participant self-report and subsequent physician review of medical records . This is re source -intensive . Herein , we assess whether Medicare data can reliably assess stroke events in the WHI . Methods — Subjects were WHI participants with fee-for-service Medicare . Four stroke definitions were created for Medicare data using discharge diagnoses in hospitalization cl aims : definition 1 , stroke codes in any position ; definition 2 , primary position stroke codes ; and definitions 3 and 4 , hemorrhagic and ischemic stroke codes , respectively . WHI data were r and omly split into training ( 50 % ) and test sets . A concordance matrix was used to examine the agreement between WHI and Medicare stroke diagnosis . A WHI stroke and a Medicare stroke were considered a match if they occurred within ±7 days of each other . Refined analyses excluded Medicare events when medical records were unavailable for comparison . Results — Training data consisted of 24 428 r and omly selected participants . There were 577 WHI strokes and 557 Medicare strokes using definition 1 . Of these , 478 were a match . With regard to algorithm performance , specificity was 99.7 % , negative predictive value was 99.7 % , sensitivity was 82.8 % , positive predictive value was 85.8 % , and & kgr;=0.84 . Performance was similar for test data . Whereas specificity and negative predictive value exceeded 99 % , sensitivity ranged from 75 % to 88 % and positive predictive value ranged from 80 % to 90 % across stroke definitions . Conclusions — Medicare data seem useful for population -based stroke research ; however , performance characteristics depend on the definition selected BACKGROUND Surveillance for stroke/transient ischemic attack ( TIA ) using administrative data has traditionally been limited to reporting patients who had an acute event and were hospitalized . This underestimates the true prevalence because many events do not result in hospitalization . We examined whether the accuracy of administrative data for identifying prevalent stroke/TIA could be improved by using data from both inpatient and outpatient visits . METHODS An administrative data validation reference st and ard was developed through chart abstract ion of 5000 adult patients r and omly sample d from 73,014 patients of 83 family physicians who participate in the Electronic Medical Record Administrative Data Linked Data base ( EMRALD ) , in Ontario , Canada . RESULTS The prevalence of stroke/TIA in our adult population was 3.0 % . An algorithm of 1 hospital record had a sensitivity of 35.3 % ( 27.7%-43.0 % ) and specificity of 99.8 % ( 99.7%-99.9 % ) , whereas an algorithm of 2 physician billings within 1 year or 1 hospitalization had a sensitivity of 68.0 % ( 95 % confidence interval [ CI ] , 60.5%-75.5 % ) and specificity of 98.9 % ( 95 % CI , 98.6%-99.2 % ) for the identification of patients who had ever had a stroke/TIA . We found that hospitalization data underestimated the prevalence of stroke by > 50 % and TIA by > 66 % compared with using both hospitalization and physician cl aims data . CONCLUSIONS The use of outpatient physician cl aims data in addition to hospitalization data improves the sensitivity of administrative data for the identification of prevalent stroke/TIA and may be used to estimate the prevalence of cerebrovascular events in large population s and over time Background Kappa is commonly used when assessing the agreement of conditions with reference st and ard , but has been criticized for being highly dependent on the prevalence . To overcome this limitation , a prevalence-adjusted and bias-adjusted kappa ( PABAK ) has been developed . The purpose of this study is to demonstrate the performance of Kappa and PABAK , and assess the agreement between hospital discharge administrative data and chart review data conditions . Methods The agreement was compared for r and om sampling , restricted sampling by conditions , and case-control sampling from the four teaching hospitals in Alberta , Canada from ICD10 administrative data during January 1 , 2003 and June 30 , 2003 . A total of 4,008 hospital discharge records and chart view , linked for personal unique identifier and admission date , for 32 conditions of r and om sampling were analyzed . The restricted sample for hypertension , myocardial infa rct ion and congestive heart failure , and case-control sample for those three conditions were extracted from r and om sample . The prevalence , kappa , PABAK , positive agreement , negative agreement for the condition was compared for each of three sample s. Results The prevalence of each condition was highly dependent on the sampling method , and this variation in prevalence had a significant effect on both kappa and PABAK . PABAK values were obviously high for certain conditions with low kappa values . The gap between these two statistical values for the same condition narrowed as the prevalence of the condition approached 50 % . Conclusion Kappa values varied more widely than PABAK values across the 32 conditions . PABAK values should usually not be interpreted as measuring the same agreement as kappa in administrative data , particular for the condition with low prevalence . There is no single statistic measuring agreement that captures the desired information for validity of administrative data . Research ers should report kappa , the prevalence , positive agreement , negative agreement , and the relative frequency in each cell ( i.e. a , b , c and d ) to enable the reader to judge the validity of administrative data from multiple aspects Background and Purpose — Because acute ischemic strokes ( ISs ) are mainly hospitalized , hospital discharge data could be used to routinely follow their incidence management . We aim ed to assess sensitivity and positive predictive value of the French hospital discharge data base ( HDD ) to identify patients with acute IS using a prospect i ve and exhaustive cohort ( AVC69 ) of acute IS cases . Methods — A selection algorithm based on IS diagnosis coded with the International Classification of Diseases ( ICD-10 ) and cerebral imaging codes was used to identify all hospital stays with the primary diagnosis of IS in the HDD of the university hospitals of the Rhône area . Cases identified through HDD search were compared with IS cases identified through an exhaustive cohort study conducted in the Rhône district and confirmed on medical records review . Results — There were 465 confirmed cases of IS hospitalized in 1 of the 4 university hospitals during the study period . The HDD search identified 313 among those ( true-positive cases ) but missed 152 cases ( false-negative cases ) . The sensitivity of the HDD search was 67.3 % ( 95 % confidence interval , 63.1–71.5 ) , and the positive predictive value was 95.1 % ( 95 % confidence interval , 92.8–97.4 ) . Additionally , HDD search retrieved 16 cases , which were not eventually IS ( false positives ) . Sensitivity was better when patients were hospitalized in neurological departments . Conclusions — The lack of sensitivity to identify acute IS patients through HDD search does not seem to be accurate enough to vali date the use of these data for incidence estimates . Efforts have to be made to improve the coding quality Background and Purpose — Surveillance is necessary to underst and and meet the future dem and s stroke will place on health care . Administrative data are the most accessible data source for stroke surveillance in Canada . The International Classification of Diseases , 10th revision ( ICD-10 ) coding system has potential improvements over ICD-9 for stroke classification . Our purpose was to compare hospital discharge abstract coding using ICD-9 and ICD-10 for stroke and its risk factors . Methods — We took advantage of a switch in coding systems from ICD-9 to ICD-10 to independently review stroke patient charts . From time periods April 2000 to March 2001 , 717 charts , and from April 2002 to March 2003 , 249 charts were r and omly selected for review . Using a before- and -after time period design , the accuracy of hospital coding of stroke ( part I ) and stroke risk factors ( part II ) using ICD-9 and ICD-10 was compared . We used careful definitions of stroke and its types based on ICD-9 using the fourth and fifth digit modifier codes . Results — Stroke coding was equally good with ICD-9 ( 90 % [ CI95 86 to 93 ] correct ) and ICD-10 [ 92 % ( CI95 88 to 95 correct ) with ICD-10 . There were some differences in coding by stroke type , notably with transient ischemic attack , but these differences were not statistically significant . Atrial fibrillation , coronary artery disease/ischemic heart disease , diabetes mellitus , and hypertension were coded with high sensitivity ( 81 % to 91 % ) and specificity ( 83 % to 100 % ) . ICD-10 was as good as ICD-9 for stroke risk factor coding . Conclusions — Passive surveillance using administrative data are a useful tool for identifying stroke and its risk factors using both ICD-9 and ICD-10 Background The burden of stroke is high and increasing in China . We modelled variations in , and predictors of , the costs of hospital care for patients with acute stroke in China . Methods and Findings Baseline characteristics and hospital costs for 5,255 patients were collected using the prospect i ve register-based ChinaQUEST study , conducted in 48 Level 3 and 14 Level 2 hospitals in China during 2006–2007 . Ordinary least squares estimation was used to determine factors associated with hospital costs . Overall mean cost of hospitalisation was 11,216 Chinese Yuan Renminbi ( CNY ) ( Output:	While most cases of prevalent cerebrovascular disease can be detected using 430 - 438/I60-I69 collectively , acute stroke must be defined using more specific codes . Most in-hospital deaths and death certificates with stroke as a cause-of-death correspond to true stroke deaths . Linking vital statistics and hospitalization data may improve the ascertainment of fatal stroke
MS2621	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To use two different exercise programs over a 2-year period to reduce falls and their sequelae among residents of two long-term care facilities . DESIGN R and omized , controlled trial . SETTING The study took place at two long-term care facilities with services ranging from independent living to skilled nursing . PARTICIPANTS One hundred and ten participants whose average age was 84 and who were capable of ambulating with or without assistive devices and could follow simple directions . INTERVENTION Participants were r and omized to one of two exercise groups ( resistance/endurance plus basic enhanced programming or tai chi plus basic enhanced programming ) or to a control group ( basic enhanced programming only ) . Exercise classes were held three times per week throughout the study . MEASUREMENTS Participants were evaluated for cognitive and physical functioning at baseline and 6 , 12 , and 24 months . Falls were determined from incident reports filed by the nursing staffs at the facilities . RESULTS Time to first fall , time to death , number of days hospitalized , and incidence of falls did not differ among the treatment and control groups ( P>.05 ) . Among all participants , those who fell had significantly lower baseline Folstein Mini-Mental State Examination and instrumental activities of daily living scores and experienced significantly greater declines in these measures over the 2-year program . CONCLUSION There were no significant differences in falls among the two exercise groups and the control group . Lack of treatment differences and low adherence rates suggest that residents of long-term care facilities may require individualized exercise interventions that can be adapted to their changing needs BACKGROUND Although exercise has been shown to relieve depression , little is known about its mechanism or dose-response characteristics . We hypothesized that high intensity progressive resistance training ( PRT ) would be more effective than either low intensity PRT or st and ard care by a general practitioner ( GP ) in depressed elderly persons , and that high intensity PRT would provide superior benefits in quality of life , sleep quality , and self-efficacy . METHODS Sixty community-dwelling adults > 60 years with major or minor depression were r and omized to supervised high intensity PRT ( 80 % maximum load ) or low intensity PRT ( 20 % maximum load ) 3 days per week for 8 weeks , or GP care . RESULTS A 50 % reduction in the Hamilton Rating Scale of Depression score was achieved in 61 % of the high intensity , 29 % of the low intensity , and 21 % of the GP care group ( p = .03 ) . Strength gain was directly associated with reduction in depressive symptoms ( r = 0.40 , p = .004 ) , as was baseline social support network type ( F = 3.52 , p = .015 ) , whereas personality type , self-efficacy , and locus of control were unrelated to the antidepressant effect . Vitality quality -of-life scale improved more in the high intensity group than in the others ( p = .04 ) . Sleep quality improved significantly in all participants ( p < .0001 ) , with the greatest relative change in high intensity PRT ( p = .05 ) . CONCLUSIONS High intensity PRT is more effective than is low intensity PRT or GP care for the treatment of older depressed patients STUDY OBJECTIVE In the causative mechanism of falls among older community dwellers , slips and trips have been found to be significant precursors . The purpose of the two year trial was to assess the effectiveness of multi-component interventions targeting major risk factors for falls in reducing the incidence of slips , trips and falls among the well , older community . DESIGN Four groups with approximately equal numbers of participants were r and omly allocated to interventions . The prevention strategies included education and awareness raising of falls risk factors , exercise sessions to improve strength and balance , home safety advice to modify environmental hazards , and medical assessment to optimise health . The interventions combined the strategies in an add on approach . The first intervention group receiving the information session only was regarded as the control . The outcome of interest was the occurrence of a slip , trip or fall , monitored prospect ively using a daily calendar diary . PARTICIPANTS AND SETTING Two hundred and fifty two members of the National Seniors Association in the Brisbane district agreed to participate . National Seniors clubs provide a forum for active , community dwelling Australians aged 50 and over to participate in policy , personal development and recreation . MAIN RESULTS Using Cox 's proportional hazards regression model , adjusted hazard ratios comparing intervention groups with the control ranged from 0.35 ( 95 % CI 0.17 , 0.73 ) to 0.48 ( 0.25 , 0.91 ) for slips ; 0.29 ( 0.16 , 0.51 ) to 0.45 ( 0.27 , 0.74 ) for trips ; and 0.60 ( 0.36 , 1.01 ) to 0.82 ( 0.51 , 1.31 ) for falls . While calendar monitoring recorded outcome , it was also assessed as a prevention strategy by comparing the intervention groups with a hypothetical non-intervened group . At one year after intervention , reductions in the probability of slips , trips and falls ( 61(95%CI 54 , 66)% ; 56 ( 49 , 63)% ; 29 ( 22 , 36)% respectively ) were demonstrated . CONCLUSIONS This study makes an important contribution to the priority community health issue of falls prevention by showing that effective , sustainable , low cost programmes can be introduced through community-based organisations to reduce the incidence of slips , trips and falls in well , older people OBJECTIVE To assess the effectiveness of psychotropic medication withdrawal and a home-based exercise program in reducing falls in older people . DESIGN A r and omized controlled trial with a two by two factorial design . SETTING Seventeen general practice s in Dunedin , New Zeal and . PARTICIPANTS Women and men aged 65 years registered with a general practitioner and currently taking psychotropic medication ( n = 93 ) . INTERVENTIONS Two interventions : ( 1 ) gradual withdrawal of psychotropic medication versus continuing to take psychotropic medication ( double blind ) and ( 2 ) a home-based exercise program versus no exercise program ( single blind ) . MEASUREMENTS Number of falls and falls risk during 44 weeks of follow-up . Analysis was on an intent to treat basis . RESULTS After 44 weeks , the relative hazard for falls in the medication withdrawal group compared with the group taking their original medication was .34 ( 95 % CI , .16-.74 ) . The risk of falling for the exercise program group compared with those not receiving the exercise program was not significantly reduced . CONCLUSIONS Withdrawal of psychotropic medication significantly reduced the risk of falling , but permanent withdrawal is very difficult to achieve OBJECTIVES This r and omized controlled trial studied the effects of a low- to moderate-intensity group exercise program on strength , endurance , mobility , and fall rates in fall-prone elderly men with chronic impairments . METHODS Fifty-nine community-living men ( mean age = 74 years ) with specific fall risk factors ( i.e. , leg weakness , impaired gait or balance , previous falls ) were r and omly assigned to a control group ( n = 28 ) or to a 12-week group exercise program ( n = 31 ) . Exercise sessions ( 90 minutes , three times per week ) focused on increasing strength and endurance and improving mobility and balance . Outcome measures included isokinetic strength and endurance , five physical performance measures , and self-reported physical functioning , health perception , activity level , and falls . RESULTS Exercisers showed significant improvement in measures of endurance and gait . Isokinetic endurance increased 21 % for right knee flexion and 26 % for extension . Exercisers had a 10 % increase ( p < .05 ) in distance walked in six minutes , and improved ( p < .05 ) scores on an observational gait scale . Isokinetic strength improved only for right knee flexion . Exercise achieved no significant effect on hip or ankle strength , balance , self-reported physical functioning , or number of falls . Activity level increased within the exercise group . When fall rates were adjusted for activity level , the exercisers had a lower 3-month fall rate than controls ( 6 falls/1000 hours of activity vs 16.2 falls/1000 hours , p < .05 ) . DISCUSSION These findings suggest that exercise can improve endurance , strength , gait , and function in chronically impaired , fall-prone elderly persons . In addition , increased physical activity was associated with reduced fall rates when adjusted for level of activity Background : The knowledge concerning balance training actually lowering fall rates among frail older persons is limited . Objective : The aim of this study was to examine the effects of a 4-week individualized visual feedback-based balance training on the fall incidence during 1-year follow-up among frail older women living in residential care . Methods : Twenty-seven older women from 2 residential care homes were r and omized into exercise ( n = 20 ) and control ( n = 7 ) groups . Balance measurements were carried out before and after a 4-week training period and falls were monitored by monthly diaries for 1 year . An interview about fear of falling and physical activity was completed before and after the intervention and after the 1-year follow-up . Results : A positive effect of balance training on fall incidence was found . A dynamic Poisson regression model showed that during the follow-up the monthly risk of falling was decreased in the exercise group compared to controls ( risk ratio 0.398 , 95 % CI 0.174–0.911 , p = 0.029 ) . In addition , the exercise group reported a reduced fear of falling and increased physical activity after a training period but these changes declined during the follow-up period . Conclusion : Individualized visual feedback-based balance training was shown to be a promising method for fall prevention among frail older women . High compliance ( 97.5 % ) with the training program showed that carefully targeted training programs can be carried out among older people with health limitations Community trials involve the assignment of intact social groups to study conditions and are becoming increasingly common in epidemiologic research . In both the design and analysis of these studies , whether cross-sectional or cohort , allowance must be made for the dependence of elements within intact groups if variances are to be properly estimated . In the design phase , the statistician needs estimates of the level of dependence likely to be encountered . In the analysis phase , external estimates of the level of dependence may be useful in preventing the erosion of power associated with small numbers of intact groups assigned to each condition . We report the intraclass correlation coefficients of the city-year component of variance as estimated in the Minnesota Heart Health Program for a variety of community survey variables and illustrate their use in both design and analysis . Of 23 variables assessed , all but two showed positive estimates of city-year intraclass correlations . In these data , estimates of intraclass correlation coefficients generally were in the range 0.002–0.012 OBJECTIVE To evaluate the effects of two exercise approaches , Tai Chi ( TC ) and computerized balance training ( BT ) , on specified primary outcomes ( biomedical , functional , and psychosocial indicators of frailty ) and secondary outcomes ( occurrence of falls ) . DESIGN The Atlanta FICSIT ( Frailty and Injuries : Cooperative Studies of Intervention Techniques ) , a prospect i ve , r and omized , controlled clinical trial with three arms ( TC , BT , and education [ ED ] . Intervention length was 15 weeks , with primary outcomes measured before and after intervention and at 4-month follow-up . Falls were monitored continuously throughout the study . SETTING Persons aged 70 and older living in the community . PARTICIPANTS A total of 200 participants , 162 women and 38 men ; mean age was 76.2 . MEASUREMENTS Biomedical ( strength , flexibility , cardiovascular endurance , body composition ) , functional ( IADL ) , and psychosocial well-being ( CES-D scale , fear of falling question naire , self-perception of present and future health , mastery index , perceived quality of sleep , and intrusiveness ) variables . RESULTS Grip strength declined in all groups , and lower extremity range of motion showed limited but statistically significant changes . Lowered blood pressure before and after a 12-minute walk was seen following TC participation . Fear of falling responses and intrusiveness responses were reduced after the TC intervention compared with the ED group ( P = .046 and P = .058 , respectively ) . After adjusting for fall risk factors , TC was found to reduce the risk of multiple falls by 47.5 % . CONCLUSIONS A moderate TC intervention can impact favorably on defined biomedical and psychosocial indices of frailty . This intervention can also have favorable effects upon the occurrence of falls . Tai Chi warrants further study as an exercise treatment to improve the health of older people BACKGROUND Community physiotherapy is often prescribed for stroke patients with long-term mobility problems . We aim ed to assess the effectiveness of this treatment in patients who had mobility problems 1 year after stroke . METHODS We screened 359 patients older than 50 years for a single-masked , r and omised controlled trial to assess the effects of community physiotherapy . Assessment s were made at baseline , 3 , 6 , and 9 months in 170 eligible patients assigned treatment or no intervention . The primary outcome measure was mobility measured by the Rivermead mobility index . Secondary outcome measures were gait speed , number of falls , daily activity ( Barthel index scores ) , social activity ( Frenchay activities index ) , hospital anxiety and depression scale , and emotional stress of carers ( general health question naire 28 ) . Analyses were by intention to treat . FINDINGS Follow-up was available for 146 patients ( 86 % ) . Changes in scores on the Rivermead mobility index ( score range 0 - 15 ) differed significantly between treatment and control groups at 3 months ( p=0.018 ) , but only by a median of 1 point ( 95 % CI 0 - 1 ) , with an interpolated value of 0.55 ( Output:	CONCLUSION Exercise can prevent falls in older people . Greater relative effects are seen in programs that include exercises that challenge balance , use a higher dose of exercise , and do not include a walking program .
MS2622	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Induction of hypothermia in patients with brain injury was shown to improve outcomes in small clinical studies , but the results were not definitive . To study this issue , we conducted a multicenter trial comparing the effects of hypothermia with those of normothermia in patients with acute brain injury . METHODS The study subjects were 392 patients 16 to 65 years of age with coma after sustaining closed head injuries who were r and omly assigned to be treated with hypothermia ( body temperature , 33 degrees C ) , which was initiated within 6 hours after injury and maintained for 48 hours by means of surface cooling , or normothermia . All patients otherwise received st and ard treatment . The primary outcome measure was functional status six months after the injury . RESULTS The mean age of the patients and the type and severity of injury in the two treatment groups were similar . The mean ( + /-SD ) time from injury to r and omization was 4.3+/-1.1 hours in the hypothermia group and 4.1+/-1.2 hours in the normothermia group , and the mean time from injury to the achievement of the target temperature of 33 degrees C in the hypothermia group was 8.4+/-3.0 hours . The outcome was poor ( defined as severe disability , a vegetative state , or death ) in 57 percent of the patients in both groups . Mortality was 28 percent in the hypothermia group and 27 percent in the normothermia group ( P=0.79 ) . The patients in the hypothermia group had more hospital days with complications than the patients in the normothermia group . Fewer patients in the hypothermia group had high intracranial pressure than in the normothermia group . CONCLUSIONS Treatment with hypothermia , with the body temperature reaching 33 degrees C within eight hours after injury , is not effective in improving outcomes in patients with severe brain injury BACKGROUND Cardiac arrest with widespread cerebral ischemia frequently leads to severe neurologic impairment . We studied whether mild systemic hypothermia increases the rate of neurologic recovery after resuscitation from cardiac arrest due to ventricular fibrillation . METHODS In this multicenter trial with blinded assessment of the outcome , patients who had been resuscitated after cardiac arrest due to ventricular fibrillation were r and omly assigned to undergo therapeutic hypothermia ( target temperature , 32 degrees C to 34 degrees C , measured in the bladder ) over a period of 24 hours or to receive st and ard treatment with normothermia . The primary end point was a favorable neurologic outcome within six months after cardiac arrest ; secondary end points were mortality within six months and the rate of complications within seven days . RESULTS Seventy-five of the 136 patients in the hypothermia group for whom data were available ( 55 percent ) had a favorable neurologic outcome ( cerebral-performance category , 1 [ good recovery ] or 2 [ moderate disability ] ) , as compared with 54 of 137 ( 39 percent ) in the normothermia group ( risk ratio , 1.40 ; 95 percent confidence interval , 1.08 to 1.81 ) . Mortality at six months was 41 percent in the hypothermia group ( 56 of 137 patients died ) , as compared with 55 percent in the normothermia group ( 76 of 138 patients ; risk ratio , 0.74 ; 95 percent confidence interval , 0.58 to 0.95 ) . The complication rate did not differ significantly between the two groups . CONCLUSIONS In patients who have been successfully resuscitated after cardiac arrest due to ventricular fibrillation , therapeutic mild hypothermia increased the rate of a favorable neurologic outcome and reduced mortality Background and Purpose — We undertook this study to evaluate the feasibility of inducing and maintaining moderate hypothermia with the use of endovascular rather than surface cooling . Methods — Six patients with severe acute ischemic stroke were treated with moderate hypothermia . This was induced and maintained by circulating temperature-adjusted normal saline in a closed-loop system entailing 3 balloons located near the tip of a central line , which dwelled in the inferior vena cava . Results — The mean±SD initial temperature of the patients was 37±1 ° C ( range , 35.5 ° C to 38.4 ° C ) . The pace of cooling was 1.4±0.6 ° C/h , and target temperature was reached after 3±1 hours ( range , 2 to 4.5 hours ) . During hypothermia , the maximal temperature observed was 33.4 ° C , and the minimal temperature was 32.2 ° C . Temperature deviations > 0.2 ° C or > 0.3 ° C were observed during 21 % or 10 % of the hours under hypothermia , respectively . Singultus was the only device-related complication encountered . Pulmonary infection , arterial hypotension , bradycardia , arrhythmia , and thrombocytopenia were the most common side effects . Conclusions — Induction and maintenance of hypothermia with an intravenous cooling device are feasible . The safety of this approach remains to be evaluated Objective : To report results of a r and omized pilot clinical feasibility trial of endovascular cooling in patients with ischemic stroke . Methods : Forty patients with ischemic stroke presenting within 12 hours of symptom onset were enrolled in the study . An endovascular cooling device was inserted into the inferior vena cava of those r and omized to hypothermia . A core body temperature of 33 ° C was targeted for 24 hours . All patients underwent clinical assessment and MRI initially , at days 3 to 5 and days 30 to 37 . Results : Eighteen patients were r and omized to hypothermia and 22 to receive st and ard medical management . Thirteen patients reached target temperature in a mean of 77 ± 44 minutes . Most tolerated hypothermia well . Clinical outcomes were similar in both groups . Mean diffusion-weighted imaging ( DWI ) lesion growth in the hypothermia group ( n = 12 ) was 90.0 ± 83.5 % compared with 108.4 ± 142.4 % in the control group ( n = 11 ) ( NS ) . Mean DWI lesion growth in patients who cooled well ( n = 8) was 72.9 ± 95.2 % ( NS ) . Conclusions : Induced moderate hypothermia is feasible using an endovascular cooling device in most patients with acute ischemic stroke . Further studies are needed to determine if hypothermia improves outcome Background and Purpose — Moderate hypothermia decreases ischemic damage in experimental stroke models . This multicenter study was performed to evaluate ( 1 ) the safety and feasibility of moderate hypothermia and ( 2 ) its potential to reduce intracranial hypertension in acute stroke patients . Methods — Fifty prospect i ve patients with cerebral infa rct ion involving at least the complete middle cerebral artery territory treated with moderate hypothermia were evaluated . Hypothermia was induced with the use of cooling blankets as well as alcohol and ice bags within 22±9 hours after stroke onset and maintained for 24 to 72 hours ; subsequently , patients passively rewarmed over a mean duration of 17 hours . Outcome was assessed at 4 weeks and at 3 months . Results — Time required for cooling to < 33 ° C varied from 3.5 to 11 hours . The most frequent complications of hypothermic therapy were thrombocytopenia ( 70 % ) , bradycardia ( 62 % ) , and pneumonia ( 48 % ) . Four patients ( 8 % ) died during hypothermia as a result of severe coagulopathy , cardiac failure , or uncontrollable intracranial hypertension . An additional 15 patients ( 30 % ) died during or after rewarming because of rebound increase in intracranial pressure ( ICP ) and fatal herniation . A shorter ( < 16 hours ) rewarming period was associated with a more pronounced rise of ICP . Elevated ICP values were significantly reduced under hypothermia . Neurological outcome according to the National Institutes of Health Stroke Scale score 4 weeks after stroke was 29 , and Rankin Scale score 3 months after stroke was 2.9 . Conclusions — Moderate hypothermia is feasible in patients with acute stroke , although it is associated with several side effects . Most deaths occur during rewarming as a result of excessive ICP rise . Our preliminary observation that a longer duration of the rewarming period limits the ICP increase remains to be confirmed in future studies Objective : To study the effects of mild hypothermia and associated changes in temperature-corrected PaCO2 ( cPaCO2 ) on intracranial pressure ( ICP ) , mean velocity of the middle cerebral artery ( Vm ) , and venous jugular saturation in O2 ( SjvO2 ) in patients with severe traumatic brain injury (TBI).¶ Design : Prospect i ve , observational study .¶ Setting : Intensive care unit.¶ Patients : Severe TBI patients mechanically ventilated , se date d and paralyzed.¶ Interventions : Twenty patients were subjected to four consecutive periods : ( a ) normocapnia-normothermia ; ( b ) hypocapnia-normothermia , where hypocapnia was induced by an increase in minute volume ; ( c ) hypocapnia-hypothermia , where hypocapnia was induced by hypothermia maintaining the ventilatory setting s constant ; ( d ) normocapnia-hypothermia , where normocapnia was achieved by a decrease in minute volume.¶ Measurements and results : cPaCO2 was 41 ± 8 mmHg in periods 1 and 4 , and 31 ± 7 mmHg in periods 2 and 3 . Core temperature was 37.1 ± 0.8 ° C in periods 1 and 2 , and 34.1 ± 1.1 ° C in periods 3 and 4 . End-tidal CO2 and cPaCO2 values showed no difference between periods 1 and 4 and periods 2 and 3 . ICP and Vm were dependent on cPaCO2 but independent of core temperature values . SjvO2 was related to cPaCO2 and was significantly higher during period 3 than during period 2 ( P < 0.05).¶ Conclusion : The decrease in ICP was similar when hypocapnia was induced by hyperventilation or as a result of hypothermia alone . The relationship between cPaCO2 and ICP might predict variations in ICP during changes in core temperature . Further studies are needed to confirm the cerebral metabolic effects of moderate hypothermia in TBI patients BACKGROUND Cardiac arrest outside the hospital is common and has a poor outcome . Studies in laboratory animals suggest that hypothermia induced shortly after the restoration of spontaneous circulation may improve neurologic outcome , but there have been no conclusive studies in humans . In a r and omized , controlled trial , we compared the effects of moderate hypothermia and normothermia in patients who remained unconscious after resuscitation from out-of-hospital cardiac arrest . METHODS The study subjects were 77 patients who were r and omly assigned to treatment with hypothermia ( with the core body temperature reduced to 33 degrees C within 2 hours after the return of spontaneous circulation and maintained at that temperature for 12 hours ) or normothermia . The primary outcome measure was survival to hospital discharge with sufficiently good neurologic function to be discharged to home or to a rehabilitation facility . RESULTS The demographic characteristics of the patients were similar in the hypothermia and normothermia groups . Twenty-one of the 43 patients treated with hypothermia ( 49 percent ) survived and had a good outcome --that is , they were discharged home or to a rehabilitation facility -- as compared with 9 of the 34 treated with normothermia ( 26 percent , P=0.046 ) . After adjustment for base-line differences in age and time from collapse to the return of spontaneous circulation , the odds ratio for a good outcome with hypothermia as compared with normothermia was 5.25 ( 95 percent confidence interval , 1.47 to 18.76 ; P=0.011 ) . Hypothermia was associated with a lower cardiac index , higher systemic vascular resistance , and hyperglycemia . There was no difference in the frequency of adverse events . CONCLUSIONS Our preliminary observations suggest that treatment with moderate hypothermia appears to improve outcomes in patients with coma after resuscitation from out-of-hospital cardiac arrest Ischaemic preconditioning ( short periods of ischaemia with intermittent reperfusion ) has been shown paradoxically to protect the myocardium from a subsequent longer ischaemic insult . The protection associated with preconditioning is one of the most powerful mechanisms of protection known and has been shown in every animal species investigated . However , there is no direct evidence that ischaemic preconditioning occurs in the human heart . We studied whether it was possible to precondition the human heart in a setting of coronary artery bypass surgery . The measurement of adenosine triphosphate in biopsy specimens was used as our endpoint . We believe that our results are the first to show that it may be possible to precondition and protect the human myocardium with short controlled periods of intermittent ischaemia and reperfusion Background : We hypothesized that previous transient ischemic attack ( TIA ) had a favorable effect on early outcome after acute nonlacunar ischemic stroke . Methods : Data of 1,753 consecutive patients with ischemic stroke collected from a prospect i ve hospital-based stroke registry were studied . A comparison was made of the groups with and without previous TIA . Favorable outcome included spontaneous neurological recovery or grade s 0–2 of the modified Rankin scale at hospital discharge . Results : Previous TIA occurred in 55 ( 11.5 % ) of 484 patients with lacunar stroke and in 166 ( 13.1 % ) of 1 Output:	RESULTS Although the mechanisms of protection for both therapeutic strategies are multifold , both share features of downregulating metabolism .
MS2623	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We performed a r and omized , prospect i ve clinical trial comparing intratracheal administration of human surfactant with conventional treatment with intermittent m and atory mechanical ventilation alone for treatment of severe respiratory distress syndrome in preterm infants of less than 30 weeks gestation . Twenty-two infants ( mean gestational age 27.0 weeks , mean birth weight 987 gm ) were given surfactant , and 23 infants ( mean gestational age 27.2 week , mean birth weight 1055 gm ) received intermittent m and atory ventilation . Infants given surfactant required less FiO2 during the first week , had lower mean airway pressure during the first 48 hours , and had improved ventilatory index and a/A PO2 ratio . Death or the occurrence of bronchopulmonary dysplasia was significantly less among infants given surfactant ( P = 0.019 ) . Pneumothorax , pulmonary interstitial emphysema , and need for FiO2 greater than or equal to 0.3 for greater than 30 days was significantly less in the surfactant group . This trial confirms the efficacy of treatment with human surfactant in preterm infants with severe respiratory distress syndrome We carried out a multicenter r and omized , placebo-controlled trial to evaluate the efficacy and safety of surfactant in the treatment of respiratory distress syndrome . The study population was made up of newborn infants weighing 750 to 1750 g who were receiving assisted ventilation with 40 percent or more oxygen . The eligible infants received a single dose of either surfactant ( 100 mg of phospholipid per kilogram of body weight [ 4 ml per kilogram ] ) or an air placebo ( 4 ml per kilogram ) , administered into the trachea within eight hours of birth by an investigator not involved in the clinical care of the infant . When compared with the infants who received the placebo ( n = 81 ) , the infants who were treated with surfactant ( n = 78 ) had a 0.12 greater average increase in the ratio of arterial to alveolar oxygen tension ( P less than 0.0001 ) , a 0.20 greater average decrease in the fractional inspiratory oxygen concentration ( P less than 0.0001 ) , and a 0.26-kPa greater average decrease in the mean airway pressure ( P less than 0.0001 ) during the 72 hours after treatment . Pneumothorax was less frequent among the infants treated with surfactant than in the control group ( 13 percent vs. 37 percent ; P = 0.0005 ) . There were no statistically significant differences between the groups in the proportion of infants in each of five ordered clinical -status categories on day 7 ( P = 0.08 ) or day 28 ( P = 0.75 ) after treatment . There were also no significant differences between the groups in the frequency of bronchopulmonary dysplasia , patent ductus arteriosus , necrotizing enterocolitis , or periventricular-intraventricular hemorrhage . In each group , 17 percent of the infants died by day 28 . We conclude that treatment with the single-dose surfactant regimen used in this study reduces the severity of respiratory distress during the 72 hours after treatment and decreases the frequency of pneumothorax , but that it does not significantly improve clinical status later in the neonatal period and does not reduce neonatal mortality . Further study of different surfactant regimens and patient- selection criteria will be required to determine whether this initial improvement can be translated into reductions in mortality or serious morbidity In a double-blind clinical trial the effects of a single dose of reconstituted bovine surfactant ( ' Surfactant TA ' ) were assessed in 30 premature infants ( birthweight 751 - 1750 g ) with severe hyaline membrane disease . 17 infants had a sonicated saline suspension of 100 mg/kg surfactant phospholipid instilled into the trachea at 5.0 ( SD 0.7 ) hours of age and 13 infants received saline by the same route at 4.3 ( 1.1 ) hours of age . In the surfactant-treated group there was early improvement in oxygenation and ventilation . Haemodynamically significant patent ductus arteriosus occurred more often in the surfactant group ; pneumothorax and pulmonary interstitial emphysema occurred less often . The combined incidence of death and severe bronchopulmonary dysplasia was significantly lower in the surfactant group ( 3/17 ) than in the placebo group ( 9/13 ) The postnatal growth , respiratory status and neurodevelopmental outcome of surviving babies enrolled in the first European multicentre trial of porcine surfactant ( Curosurf ) replacement for severe neonatal respiratory distress syndrome , were assessed at corrected ages of 1 and 2 years . Follow up rates of survivors were 93 % at 1 year and 89 % at 2 years . Treated and control groups were similar at both 1 and 2 years in terms of physical growth , the prevalence of persistent respiratory symptoms and the occurrence of major and minor disability . Serum antibodies recognising Curosurf and surfactant-anti-surfactant immune complexes were detected in both treated and control babies , the titres showing no difference between groups . Examination of histological lung sections from non-survivors revealed a higher incidence of severe pulmonary interstitial emphysema in control babies than in those treated with surfactant . Surfactant treatment for severe respiratory distress syndrome reduces neonatal mortality and air leaks and is not associated with an increase in disability 2 years later Treatment with bovine surfactant ( SF-RI 1 ) was shown to be efficacious in improving pulmonary function and in increasing survival rate without BPD in very premature infants . Surfactant therapy did not affect the risk of major complications of prematurity We conducted a prospect i ve , r and omized , unblinded , controlled trial of exogenous bovine surfactant ( surfactant TA ) in premature infants requiring ventilator support for the treatment of severe hyaline membrane disease . Forty-one low birth weight infants with severe hyaline membrane disease were r and omly assigned to saline or surfactant therapy and treated within eight hours of birth . Significant improvements in oxygenation ( increased arterial/alveolar PO2 ) and respiratory support ( decreased mean airway pressure ) were seen in the group receiving surfactant within four hours after treatment . These improvements were maintained in the surfactant-treated infants , who also had fewer pneumothoraces and fewer number of days in environments of fractional inspiratory oxygen greater than 0.4 mm Hg . No problems were associated with administration of surfactant , and no acute side effects were detected . We conclude that exogenous surfactant , administered early in the course of severe hyaline membrane disease , is an effective therapy that can diminish the amount of respiratory support required during the first 48 hours of life The results obtained with porcine surfactant ( Curosurf ) administration for the treatment of hyaline membrane disease ( HMD ) are reported . Thirty premature infants weighing 700 to 2,000 g with severe HMD ( mechanical ventilation and oxygen requirement ( FiO2 ) greater than 60 % were r and omly allocated at 2 to 15 hours postnatal age . Eight of the 30 patients included in this group participated in a multicenter european trial . The fifteen infants with mean gestational age ( GA ) of 29.5 weeks included in the treatment group ( T ) , were treated at 8.6 hours of life with a single dose of 200 mg/kg Curosurf given intratracheally while 15 infants of mean GA 30 weeks formed the control group ( C ) . Infants in the T group showed an immediate , dramatic and sustained improvement of oxygenation as reflected by increased PaO2/FiO2 and arterial to alveolar PO2 ratios within 1 hour . This significant improvement in favor of T group ( p less than 0.005 ) persisted for 2 days when control infants began to recover . This improvement in oxygenation allowed a significant decrease of FiO2 ( p less than 0.005 ) and mean airway pressure ( p less than 0.01 ) in the T group within 1 hour and up till the second day . Despite this early improvement obtained with Curosurf the survival rate at 28 days of life and the incidence of associated HMD complications were not significantly modified . However the tendency was towards decreased respiratory morbidity . The discussion will consider the value of multiple doses We investigated the clinical efficacy of a new surfactant product , Curosurf , isolated from porcine lungs by liquid-gel chromatography . Ten premature newborn infants ( birth weight 850 - 1850 g ) , all ventilated artificially for severe hyaline membrane disease categorized radiologically as stage III-IV , received a single dose of Curosurf ( 200 mg/kg ) via the tracheal tube . This treatment result ed in a rapid improvement of oxygenation , similar to that observed by other teams collaborating in the study and , in an astonishingly fast resolution of the radiological changes . In comparison with a control group of 8 infants , the surfactant-treated babies also had a lower incidence of acute and chronic complications In a r and omized , controlled study , human surfactant derived from amniotic fluid was administered within 12 hours of birth to infants with severe respiratory distress syndrome who were born at 24 to 32 weeks of gestation weighing less than or equal to 1500 gm . A second dose of surfactant was given to patients in the treatment group if they met ventilator requirements indicating relapse or lack of response to the initial dose . No significant improvement was observed in mortality rate ( 9/28 vs 15/31 ) or incidence of bronchopulmonary dysplasia ( 5/28 vs 3/31 ) when surfactant-treated infants were compared with control subjects , although there was a significant reduction in initial respirator and inspired oxygen requirements and the arterial/alveolar oxygen ratio improved . In addition , there was a significant reduction in pulmonary air leak in treated infants ( 10/28 vs 20/31 ; p less than 0.05 ) . Retreatment was associated with an attenuated ventilatory response and with a higher mortality rate ( 7/14 ) than that of infants who did not require a second dose ( 2/14 ; p = 0.05 ) , indicating a more severe form of disease . Multiple discriminant analysis , including eight independent variables , revealed that increasing birth weight , earlier age at surfactant treatment , and female gender were significantly associated with survival . These data suggest that early surfactant treatment may reduce mortality rates in very low birth weight infants with severe respiratory distress syndrome , as well as reduce ventilator requirements and the incidence of pulmonary air leaks To determine if outcomes of low birth weight neonates with respiratory distress syndrome can be improved by the administration of multiple doses of bovine surfactant , we conducted two identical multicenter , controlled trials , and the results were combined for analysis . Seven hundred and ninety-eight neonates weighing 600 to 1750 g at birth who had developed respiratory distress syndrome within 6 hours of birth were assigned r and omly to receive either 100 mg of phospholipid/kg of Survanta , a modified bovine surfactant ( n = 402 ) , or a sham dosing procedure ( n = 396 ) . Neonates whose respiratory distress persisted could be given up to three more doses , with all doses to be given in the first 48 hours after birth . Dosing was performed by investigators not involved in the clinical care of the neonates ; nursery staff were kept blinded as to the treatment assignment . Fewer Survanta-treated neonates died of any cause ( 18.4 % vs 27.3 % , P = .002 ) , died of respiratory distress syndrome ( 9.0 % vs 20.3 % , P less than .001 ) , and either died or developed bronchopulmonary dysplasia due to respiratory distress syndrome ( 51.2 % vs 64.6 % , P less than .001 ) . Neonates who received Survanta also had greater improvement in their oxygenation and ventilatory status from baseline to 72 hours than did control neonates . Survanta-treated neonates were at lowered risk for developing pulmonary interstitial emphysema ( 18.6 % vs 39.3 % , P less than .001 ) and other pulmonary air leaks ( 11.5 % vs 25.9 % , P less than .001 ) . We conclude that multiple doses of Survanta given after diagnosis of respiratory distress syndrome reduce mortality and morbidity We assessed postnatal growth , neurodevelopmental outcome , and occurrence of respiratory illnesses in 46 infants of very low birth weight who were enrolled in a r and omized , controlled , bicenter clinical trial of human surfactant treatment for respiratory distress syndrome . No long-term adverse effects of human surfactant treatment were detected between control and human surfactant-treated infants with respect to growth , neurologic , or developmental outcome . Infants with chronic lung disease , regardless of treatment group , had poorer growth and were more likely to have neurodevelopmental abnormalities at 12 to 24 months of age Several r and omized clinical trials have shown that surfactant therapy improves the pulmonary status of infants with respiratory distress syndrome and has the potential to reduce morbidity and mortality in these infants . Relatively little is known , however , about the long-term consequences of surfactant treatment . In this report , the results of health and developmental assess Output:	The studies demonstrated an initial improvement in respiratory status ( improved oxygenation and decreased need for ventilator support ) . AUTHORS ' CONCLUSIONS Infants with established respiratory distress syndrome who receive animal derived surfactant extract treatment have a decreased risk of pneumothorax , a decreased risk of pulmonary interstitial emphysema , a decreased risk of mortality , and a decreased risk of bronchopulmonary dysplasia or death
MS2624	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background —Diagnostic strategies with ECG and serum cardiac markers have been used to rule out acute myocardial infa rct ion in 6 to 12 hours . The present study evaluated whether a multimarker strategy that used point-of-care measurement of myoglobin , creatine kinase (CK)-MB , and troponin I could exclude acute myocardial infa rct ion in ≤3 hours . Methods and Results —We prospect ively enrolled consecutive patients ( n=817 ) in the emergency department who were evaluated for possible acute myocardial infa rct ion . In patients with nondiagnostic ECGs , we measured CK-MB , troponin I , and myoglobin with a point-of-care device at presentation and at 90 minutes , 3 hours , and 9 hours . St and ard central laboratory testing of CK-MB was done at the same time intervals , and triage decisions were made by emergency physicians who were unaware of point-of-care results . Sensitivity and negative predictive value were compared for both the multimarker , point-of-care approach and the central laboratory strategy . Sensitivity and negative predictive value for point-of-care combination of myoglobin and troponin I by 90 minutes was 96.9 % and 99.6 % , respectively . CK-MB measurements and blood sampling at 3 hours did not improve sensitivity or negative predictive value . Median time from sampling to reporting of results was 71.0 minutes for the central laboratory versus 24.0 minutes for the point-of-care device ( P < 0.001 ) . Conclusions —Acute myocardial infa rct ion can be excluded rapidly in the emergency department by use of point-of-care measurements of myoglobin and troponin I during the first 90 minutes after presentation ABSTRACT The diagnosis of severe pneumococcal infections is inadequate , relying heavily on culture of Streptococcus pneumoniae from blood or other normally sterile fluids , and is severely limited by prior administration of antibiotics . We evaluated prospect ively the Binax NOW S. pneumoniae urinary antigen test , a rapid immunochromatographic assay , for the diagnosis of bacteremic pneumococcal infections in hospitalized adult patients . Antigen was detected in 88 of 107 cases overall , result ing in a test sensitivity of 82 % ( 95 % confidence interval [ 95 % CI ] , 74 to 89 % ) . Antigen detection was greater in those with pneumonia ( 67 of 77 [ 87 % ] ) than in those without pneumonia ( 21 of 30 [ 70 % ] ) ( P = 0.04 ) . Urinary antigen was also detected in 3 of 106 adult patients with community-acquired septicemic infections caused by other organisms , giving a test specificity of 97 % ( 95 % CI , 92 to 99 % ) . For 45 pneumococcal bacteremia patients with a positive test on treatment day 1 , urinary antigen excretion was monitored for the first week of antibiotic treatment . Antigen was still detectable in 83 % ( 29 of 35 tested ; 95 % CI , 66 to 93 % ) on treatment day 3 . Detection of urinary antigen is a valuable , sensitive , and rapid test for the early diagnosis of bacteremic pneumococcal infections in adult patients , even after antibiotic treatment has commenced BACKGROUND : The rapidly evolving p and emic of novel 2009 swine-origin influenza A ( H1N1 ) virus ( S-OIV ) dem and s that accurate and practical diagnostics be urgently evaluated for their potential clinical utility . OBJECTIVE : To determine the diagnostic accuracy of a rapid influenza diagnostic test ( RIDT ) and direct fluorescent antibody ( DFA ) assay for S-OIV by using reverse-transcription polymerase chain reaction ( RT-PCR ) as the reference st and ard . METHODS : We prospect ively recruited children ( aged 0–17 years ) assessed in the emergency department of a pediatric referral hospital and a community pediatric clinic for influenza-like illness between May 22 and July 25 , 2009 . RIDT ( performed on-site ) and DFA were compared with RT-PCR to determine their sensitivity and specificity for S-OIV . We also compared the sensitivity of RIDT for S-OIV to that for seasonal influenza over 2 preceding seasons . RESULTS : Of 820 children enrolled , 651 were from the emergency department and 169 were from the clinic . RIDT sensitivity was 62 % ( 95 % confidence interval [ CI ] : 52%–70 % ) for S-OIV , with a specificity of 99 % ( 95 % CI : 92%–100 % ) . DFA sensitivity was 83 % ( 95 % CI : 75%–89 % ) and was superior to that of RIDT ( P < .001 ) . RIDT sensitivity for S-OIV was comparable to that for seasonal influenza when using DFA supplemented with culture as the reference st and ard . RIDT sensitivity for influenza viruses was significantly higher in children 5 years of age or younger ( P = .003 ) and in patients presenting ≤2 days after symptom onset ( P < .001 ) . CONCLUSIONS : The sensitivity of RIDT for detection of S-OIV is higher than recently reported in mixed adult-pediatric population s but remains suboptimal INTRODUCTION The cost-effectiveness of blood cultures in community-acquired pneumonia ( CAP ) has been question ed . Although penicillin-resistant Streptococcus pneumoniae is an increasing problem , penicillin therapy , where appropriate , reduces cost and may reduce antibiotic resistance . Blood cultures , however , can only reduce cost if physicians are prepared to alter therapy based on the results . We review ed our experience to determine how often physicians changed management based on blood culture results positive for S pneumoniae . METHODS Retrospective chart review was performed of all CAP admissions between January 1996 and December 1998 with blood culture results positive for S pneumoniae . RESULTS Seventy-four patients out of 1,805 patients admitted with CAP during this period had pneumococcemia . Penicillin resistance was identified in 15 cases ( 20.3 % ; high grade in 4 cases ) with cephalosporin resistance in 4 of these cases ( 1 high grade ) . Fifty-one patients had initial empiric therapy with a third-generation cephalosporin , and 58 patients had empiric coverage of atypical organisms ; no patient received empiric penicillin therapy . Blood culture results altered management in 31 patients ( 41.9 % ) , but in only 2 cases was this due to antibiotic resistance . Fifty-one patients without penicillin allergy grew penicillin-sensitive pneumococci ; only 11 patients ( 21.6 % ) were changed to penicillin therapy . Thirteen of 35 patients ( 37.1 % ) who were given an additional antibiotic for atypical coverage had this antibiotic ceased . CONCLUSION Despite evidence of penicillin-sensitive pneumococcal CAP , physicians were reluctant to narrow antibiotic therapy , potentially adding to treatment cost and reducing the impact of blood culture results on management . The impact of penicillin resistance was reduced by the usual empiric choice of a third-generation cephalosporin . While positive blood culture results can clearly be useful in the management of patients with CAP , their cost-effectiveness needs to be assessed in prospect i ve clinical trials Background With the current influenza A H1N1 p and emic ( H1N1pdm ) , it is extremely important that clinicians can quickly and accurately identify influenza cases . Methodology /Principal Findings To investigate the performance of the QuickVue Influenza A+B rapid test , we conducted a prospect i ve study of the diagnostic accuracy of the QuickVue Influenza A+B test compared to real-time reverse transcriptase-polymerase chain reaction ( RT-PCR ) for influenza A H1N1pdm in Nicaraguan children aged 2 to 14 years . Rapid test sensitivity and specificity compared to real-time RT-PCR were 64.1 % ( 95 % CI 53.5 , 73.9 ) and 98.3 % ( 95.0 , 99.6 ) , respectively . Agreement between the two tests was 86.4 % ( 95 % CI 81.7 , 90.3 ) , and kappa was calculated to be 0.67 ( 95 % CI 0.56 , 0.76 ) . Performance of the rapid test varied by day of presentation , with a sensitivity of 41.7 % ( 95 % CI 22.1 , 63.4 ) for sample s from children presenting on the day of symptom onset and a sensitivity of 72.1 % ( 95 % CI 59.9 , 82.3 ) for sample s from children presenting one or more days post-symptom onset . Conclusions / Significance We found that the rapid test performed with moderate sensitivity and high specificity . Test performance varied by day of onset , with lower sensitivity on the day of symptom onset BACKGROUND Little is known about the impact of community-acquired respiratory coinfection in patients with p and emic 2009 influenza A(H1N1 ) virus infection . METHODS This was a prospect i ve , observational , multicenter study conducted in 148 Spanish ICUs . RESULTS Severe respiratory syndrome was present in 645 ICU patients . Coinfection occurred in 113 ( 17.5 % ) of patients . Streptococcus pneumoniae ( in 62 patients [ 54.8 % ] ) was identified as the most prevalent bacteria . Patients with coinfection at ICU admission were older ( 47.5±15.7 vs 43.8±14.2 years , P<.05 ) and presented a higher APACHE ( Acute Physiology and Chronic Health Evaluation ) II score ( 16.1±7.3 vs 13.3±7.1 , P<.05 ) and Sequential Organ Failure Assessment ( SOFA ) score ( 7.0±3.8 vs 5.2±3.5 , P<.05 ) . No differences in comorbidities were observed . Patients who had coinfection required vasopressors ( 63.7 % vs 39.3 % , P<.05 ) and invasive mechanical ventilation ( 69 % vs 58.5 % , P<.05 ) more frequently . ICU length of stay was 3 days longer in patients who had coinfection than in patients who did not ( 11 [ interquartile range , 5 - 23 ] vs 8 [ interquartile range 4 - 17 ] , P=.01 ) . Coinfection was associated with increased ICU mortality ( 26.2 % vs 15.5 % ; OR , 1.94 ; 95 % CI , 1.21 - 3.09 ) , but Cox regression analysis adjusted by potential confounders did not confirm a significant association between coinfection and ICU mortality . CONCLUSIONS During the 2009 p and emics , the role played by bacterial coinfection in bringing patients to the ICU was not clear , S pneumoniae being the most common pathogen . This work provides clear evidence that bacterial coinfection is a contributor to increased consumption of health re sources by critical patients infected with the virus and is the virus that causes critical illness in the vast majority of cases BACKGROUND The role of pneumococcal urinary antigen detection in the treatment of adults with community-acquired pneumonia ( CAP ) is not well defined . We assessed the usefulness of pneumococcal urinary antigen detection in the diagnosis and antimicrobial guidance in patients hospitalized with CAP . METHODS A prospect i ve study of all adults hospitalized with CAP was performed from February 2007 through January 2008 . To evaluate the accuracy of the test , we calculated its sensitivity , specificity , positive and negative predictive values , and positive and negative likelihood ratios . The gold st and ard used for diagnosis of pneumococcal pneumonia was isolation in blood or pleural fluid ( definite diagnosis ) and isolation in sputum ( probable diagnosis ) . Antibiotic modifications , complications , and mortality were analyzed . RESULTS A total of 474 episodes of CAP were included . Streptococcus pneumoniae was the causative pathogen in 171 cases ( 36.1 % ) . It was detected exclusively by urinary antigen test in 75 cases ( 43.8 % ) . Sixty-nine patients had CAP caused by a pathogen other than S pneumoniae . Specificity was 96 % , positive predictive value ranged from 88.8 % to 96.5 % , and the positive likelihood ratio ranged from 14.6 to 19.9 . The results of the test led the clinicians to reduce the spectrum of antibiotics in 41 patients . Pneumonia was cured in all of them . Potentially , this optimization would be possible in the 75 patients diagnosed exclusively by the test . CONCLUSION When its findings are positive , the pneumococcal urinary antigen test is a useful tool in the treatment of hospitalized adult patients with CAP because it may allow the clinician to optimize antimicrobial therapy with good clinical outcomes Background : Mucosal coinfections with respiratory viruses and Streptococcus pneumoniae are common , but the role of rhinovirus infections in the development of invasive pneumococcal disease ( IPD ) in children has not been studied . Methods : During 1995 and 2007 , we analyz Output:	RESULTS There was no evidence of association between diagnostic group and prescribing or clinical outcomes . All tests had limitations . We found no evidence that POCTs for influenza or S. pneumoniae , or PCR for influenza or RSV influenced antimicrobial prescribing or clinical outcomes . The total costs and QALYs of each diagnostic strategy were similar , although , incrementally , PCR was the most cost-effective strategy . The analysis does not support routine use of POCTs for either influenza or pneumococcal antigen for adults presenting with acute cardiopulmonary conditions , but suggests that conventional viral culture for clinical diagnosis should be replaced by PCR .
MS2625	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Managing children with influenza-like illness is associated with costly and painful interventions because , in order to distinguish viral from bacterial infections , diagnostic tests ( including routine blood examinations and chest radiographs ) are frequently performed,1,2 and the empirical use of antimicrobial agents is common.3 Various rapid diagnostic techniques for the detection of influenza viruses have been developed , but few data are available on their impact on child care.2,4,5 The aim of this study was to assess the effect of a rapid diagnosis of influenza infection on the management of children with influenza-like illness in an emergency department . All patients seen for influenza-like illness from 6 January to 27 February 2002 , at the paediatric emergency department of the University of Milan , Italy , were enrolled and blindly r and omly assigned in a 1:1 ratio to undergo a rapid test for the detection of influenza viruses or no rapid test . Influenza-like illness was defined as an axillary temperature of ⩾37.8 ° C and at least one symptom of acute upper or lower respiratory tract disease.6 The patients who underwent the test had their throats swabbed after vigorously rubbing both tonsillar surfaces and the posterior pharynx ; the swab was then immediately su bmi tted to the Quickvue influenza test ( Quidel , Milan , Italy ) for the rapid detection of influenza A and B viruses . The test , which has an overall sensitivity of 74–95 % and an overall specificity of 76–98%,5,7,8 was performed by a postgraduate student in accordance with the manufacturer ’s recommendations . The results were available after 10 OBJECTIVE To determine the impact of the rapid diagnosis of influenza on physician decision-making and patient management , including laboratory tests and radiographs ordered , patient charges associated with these tests , antibiotics/antivirals prescribed , and length of time to patient discharge from the emergency department . METHODS Patients aged 2 months to 21 years presenting to an urban children 's teaching hospital emergency department were screened for fever and cough , coryza , myalgias , headache , and /or malaise . After obtaining informed consent , patients were r and omized to 1 of 2 groups : 1 ) physician receives ( physician aware of ) the rapid influenza test result ; or 2 ) physician does not receive ( physician unaware of ) the result . For patients in the physician aware group , nasopharyngeal swabs were obtained , immediately tested with the FluOIA test for influenza A and B , and the result was placed on the chart before patient evaluation by the attending physician . For the physician unaware group , nasopharyngeal swabs were obtained , stored according to manufacturer 's directions , and tested within 24 hours . Results for the physician unaware group were not disclosed to the treating physicians at any time . The 2 result ant influenza-positive groups ( aware and unaware ) were compared for laboratory and radiograph studies and their associated patient charges , antibiotic/antiviral prescriptions , and length of stay in the emergency department . RESULTS A total of 418 patients were enrolled , and 391 completed the study . Of these , 202 tested positive for influenza . Comparison of the 96 influenza-positive patients whose physician was aware of the result with the 106 influenza-positive patients whose physician was unaware of the result revealed significant reductions among the former group in : 1 ) numbers of complete blood counts , blood cultures , urinalyses , urine cultures , and chest radiographs performed ; 2 ) charges associated with these tests ; 3 ) antibiotics prescribed ; and 4 ) length of stay in the emergency department . The number of influenza-positive patients who received prescriptions for antiviral drugs was significantly higher among those whose physician was aware of the result . CONCLUSIONS Physician awareness of a rapid diagnosis of influenza in the pediatric emergency department significantly reduced the number of laboratory tests and radiographs ordered and their associated charges , decreased antibiotic use , increased antiviral use , and decreased length of time to discharge Summary Background Respiratory virus infection is a common cause of hospitalisation in adults . Rapid point-of-care testing ( POCT ) for respiratory viruses might improve clinical care by reducing unnecessary antibiotic use , shortening length of hospital stay , improving influenza detection and treatment , and rationalising isolation facility use ; however , insufficient evidence exists to support its use over st and ard clinical care . We aim ed to assess the effect of routine POCT on a broad range of clinical outcomes including antibiotic use . Methods In this pragmatic , parallel-group , open-label , r and omised controlled trial , we enrolled adults ( aged ≥18 years ) within 24 h of presenting to the emergency department or acute medical unit of a large UK hospital with acute respiratory illness or fever higher than 37·5 ° C ( ≤7 days duration ) , or both , over two winter seasons . Patients were r and omly assigned ( 1:1 ) , via an internet-based allocation sequence with r and om permuted blocks , to have a molecular POC test for respiratory viruses or routine clinical care . The primary outcome was the proportion of patients who received antibiotics while hospitalised ( up to 30 days ) . Secondary outcomes included duration of antibiotics , proportion of patients receiving single doses or brief courses of antibiotics , length of stay , antiviral use , isolation facility use , and safety . Analysis was by modified intention to treat , excluding patients who declined intervention or were withdrawn for protocol violations . This study is registered with IS RCT N , number 90211642 , and has been completed . Findings Between Jan 15 , 2015 , and April 30 , 2015 , and between Oct 1 , 2015 , and April 30 , 2016 , we enrolled 720 patients ( 362 assigned to POCT and 358 to routine care ) . Six patients withdrew or had protocol violations . 301 ( 84 % ) of 360 patients in the POCT group received antibiotics compared with 294 ( 83 % ) of 354 controls ( difference 0·6 % , 95 % CI −4·9 to 6·0 ; p=0·84 ) . Mean duration of antibiotics did not differ between groups ( 7·2 days [ SD 5·1 ] in the POCT group vs 7·7 days [ 4·9 ] in the control group ; difference −0·4 , 95 % CI −1·2 to 0·4 ; p=0·32 ) . 50 ( 17 % ) of 301 patients treated with antibiotics in the POCT group received single doses or brief courses of antibiotics ( < 48 h ) compared with 26 ( 9 % ) of 294 patients in the control group ( difference 7·8 % , 95 % CI 2·5 to 13·1 ; p=0·0047 ; number needed to test=13 ) . Mean length of stay was shorter in the POCT group ( 5·7 days [ SD 6·3 ] ) than in the control group ( 6·8 days [ 7·7 ] ; difference −1·1 , 95 % CI −2·2 to −0·3 ; p=0·0443 ) . Appropriate antiviral treatment of influenza-positive patients was more common in the POCT group ( 52 [ 91 % ] of 57 patients ) than in the control group ( 24 [ 65 % ] of 37 patients ; difference 26·4 % , 95 % CI 9·6 to 43·2 ; p=0·0026 ; number needed to test=4 ) . We found no differences in adverse outcomes between the groups ( 77 [ 21 % ] of 360 patients in the POCT group vs 88 [ 25 % ] of 354 patients in the control group ; −3·5 % , −9·7 to 2·7 ; p=0·29 ) . Interpretation Routine use of molecular POCT for respiratory viruses did not reduce the proportion of patients treated with antibiotics . However , the primary outcome measure failed to capture differences in antibiotic use because many patients were started on antibiotics before the results of POCT could be made available . Although POCT was not associated with a reduction in the duration of antibiotics overall , more patients in the POCT group received single doses or brief courses of antibiotics than did patients in the control group . POCT was also associated with a reduced length of stay and improved influenza detection and antiviral use , and appeared to be safe . Funding University of Southampton OBJECTIVE To present our experience regarding the use of a rapid diagnostic test for seasonal influenza A and B. METHODS We systematic ally collected and analyzed our data regarding the use of a rapid diagnostic test for seasonal influenza A and B in patients with specific respiratory symptoms that sought medical services , during the time period from 01/01/2009 to 30/05/2009 , from a network of physicians ( SOS Doctors ) who perform house-call visits in the area of Attica , Greece . RESULTS From the total of 16,335 house-call visits performed during the evaluated period , 3412 ( 20.8 % ) were due to respiratory/influenza symptoms ; 197 ( 5.8 % ) patients were tested for influenza . From the 184 patients with available data regarding the test result , 97 ( 52.7 % ) were positive for influenza . Significantly more oseltamivir and less antibiotic treatment were prescribed to patients with positive test result compared with those with a negative test result . Additionally , the impact of the test in the participating physicians ' decision making was obvious , as doctors who used the test systematic ally prescribed significantly more oseltamivir and less antibiotic treatment compared to the doctors who did n't use the test . CONCLUSION The use of a rapid test for seasonal influenza enabled the targeted treatment with oseltamivir , as well as a reduction in antibiotic treatment , in patients found positive for influenza in our clinical setting BACKGROUND Influenza affects many people worldwide each year and has many troublesome symptoms . We investigated the efficacy and safety of the inhaled antiviral agent zanamivir as a treatment for influenza A and B infection . METHODS In a r and omised , double-blind , placebo-controlled trial , we recruited 455 patients aged 12 years and older with influenza-like symptoms of 36 h duration or less who lived in Australia , New Zeal and , and South Africa . Eligible patients were r and omly assigned 10 mg inhaled zanamivir ( n=227 ) or placebo ( n=228 ) twice daily for 5 days . All patients recorded symptoms on diary cards four times daily during treatment and twice daily for 9 days after treatment . We analysed all patients by intention to treat , influenza-positivity , and high risk of developing complications . FINDINGS Compared with placebo , zanamavir relieved influenza symptoms a median of 1.5 days earlier in the intention-to-treat ( p=0.011 ) and influenza-positive ( p=0.004 ) population s , and 2 days earlier in patients who were febrile at entry [ corrected ] . In high-risk patients treated with zanamivir , symptoms were alleviated a median of 2.5 days earlier ( p=0.048 ) , fewer had complications ( p=0.004 ) , and fewer used complication-associated antibiotics ( p=0.025 ) compared with placebo . The adverse event profiles were similar for zanamivir and placebo . INTERPRETATION Zanamivir was well-tolerated and effective in decreasing the duration and severity of symptoms . Complications were also decreased in high-risk patients but these findings need to be confirmed in future studies due to the limited number of patients [ corrected ] OBJECTIVES Acute respiratory tract infections represent a significant burden on pediatric emergency departments ( ED ) and families . We hypothesized that early and rapid diagnosis of a viral infection alleviates the need for ancillary testing and antibiotic treatment . STUDY DESIGN We conducted a r and omized , controlled trial of children 3 to 36 months of age with febrile acute respiratory tract infections at a pediatric ED . Two hundred four subjects were r and omly assigned to receive rapid respiratory viral testing on admission or a routine ED admission protocol . Outcome measures were : mean length of visits , rate of ancillary tests , and antibiotic prescription in the ED . A follow-up call was made to all study subjects to inquire about further healthcare visits , ancillary testing , and antibiotic prescription after ED discharge . RESULTS We did not find a statistically significant difference in ED length of visits , rate of ancillary testing , or antibiotic prescription rate in the ED between the study groups . There was , however , a significant reduction in antibiotic prescription after ED discharge ( in the group who had rapid viral testing RR = 0.36 ; 95 % CI = 0.14 , 0.95 ) . CONCLUSIONS Rapid multi-viral testing in the ED did not significantly affect ED patient treatment but may reduce antibiotic prescription in the community after discharge from the ED , suggesting a novel strategy to alter community physician antibiotic prescription patterns BACKGROUND Fever is a frequent cause of medical consultation among returning travelers . The objectives of this study were to assess whether physicians were able to identify patients with influenza and whether the use of an influenza rapid diagnostic test ( iRDT ) modified the clinical management of such patients . METHODS R and omized controlled trial conducted at 2 different Swiss hospitals between December 2008 and November 2012 . Inclusion criteria were 1 ) age ≥ 18 years , 2 ) documented fever of ≥ 38 ° C or anamnestic fever + cough or s Output:	The majority of papers reporting on antiviral prescription found that a positive POCT result significantly increased use of antivirals for influenza compared with negative POCT results and st and ard supportive care . A positive POCT result also led to decreased antibiotic use . The studies assessed in this systematic review support the use of POCT for diagnosis of influenza in patients suffering an acute respiratory infection . Diagnosis using POCT may lead to more appropriate prescription of treatments for infectious agents .
MS2626	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Protein requirements in stable , adequately dialysed haemodialysis patients are not known and recommendations vary . It is not known whether increasing the dialysis dose above the accepted adequate level has a favourable effect on nutrition . The aim of this study was to determine whether prescribing a high protein diet and increasing the dose of dialysis would have a favourable effect on dietary protein intake and nutritional status in stable , adequately dialysed haemodialysis patients . Effects on hyperphosphataemia and acidosis were also studied . METHODS Patients were r and omized to a high dialysis dose ( HDD ) group ( target Kt/V(eq ) of 1.4 ) or a regular dialysis dose ( RDD ) group ( target Kt/V(eq ) of 1.0 ) . All patients were prescribed a high protein ( HP ) diet [ 1.3 g/kg of ideal body weight (IBW)/day ] and a regular protein ( RP ) diet ( 0.9 g/kg/day ) , each during 40 weeks in a crossover design . In 50 patients , 23 in the HDD and 27 in the RDD group follow-up was > or = 10 weeks . These patients , aged 56+/-15 years , were included in the analysis . Nutritional status was assessed by anthropometry , plasma albumin and a nutritional index . RESULTS Delivered Kt/V(eq ) in the HDD group ( 1.26+/-0.14 ) was significantly higher than in the RDD group ( 1.02+/-0.08 ) . Protein intake estimated from total nitrogen appearance ( PNA ) measurements and food records ( DPI ) was significantly higher during the HP diet ( PNA(IBW ) , 1.01+/-0.18 g/kg/day ; DPI(IBW ) , 1.15+/-0.18 g/kg/day ) than during the RP diet ( PNA(IBW ) , 0.90+/-0.14 g/kg/day ; DPI(IBW ) , 0.94+/-0.11 g/kg/day ) . Increasing the dialysis dose did not increase protein intake either during the HP or RP diet . Plasma albumin ( 41.9+/-3.0 g/l ) lean body mass ( 107+/-15 % of normal values ) and the nutritional index did not differ between the dialysis dose groups or protein diets and remained stable overtime . Dry body weight ( 97+/-14 % ) and total fat mass increased over time in the HDD group , but remained stable in the RDD group suggesting an effect of dialysis dose on energy balance . There was no effect of the protein diets on dry body weight or total fat mass . Plasma phosphate levels and oral bicarbonate supplements were lower in the HDD group , but were comparable between the protein diets . CONCLUSIONS Prescribing a HP diet result ed in a modest increase in actual protein intake , but increasing dialysis dose did not have a contributing effect . A HP diet or increasing the dialysis dose did not have a favourable effect on the nutritional status . A dietary protein intake of at least 0.9 g/kg IBW/day appears to be sufficient for adequately dialysed haemodialysis patients without overt malnutrition BACKGROUND Dialysis adequacy targets frequently are difficult to achieve in large hemodialysis patients . Dual dialyzers can be used to improve clearance . It is unknown whether series or parallel configurations are superior . METHODS Eighteen large hemodialysis patients ( mean weight , 92.4 kg ) were enrolled in a r and omized , crossover trial to directly compare dual dialyzers in parallel and series configurations . Treatment times , blood flow rates , and dialysate flow rates were kept constant . RESULTS Compared with a single dialyzer , parallel dual dialyzers increased the single-pool Kt/V ( spKt/V ) from 1.25 + /- 0.22 to 1.43 + /- 0.29 ( P < 0.003 ) . Series dual dialyzers improved urea clearance measured by spKt/V ( spKt/V(urea ) ) to 1.46 + /- 0.26 ( P < 0.0003 compared with a single dialyzer ) . Kt/V and urea reduction ratio of dual dialyzers in parallel were not significantly different from those of dual dialyzers in series . Half the subjects failed to meet the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative recommended adequacy target for spKt/V(urea ) of 1.2 or less using a single dialyzer . With the use of dual dialyzers , 83 % of subjects achieved this adequacy target . Serum levels of a middle molecule , beta2-microglobulin , were reduced 34 % after 2 months of dual-dialyzer therapy . Cost analysis estimates annual net savings of 1,260 dollars with dual-dialyzer therapy , primarily from projected savings in inpatient expenses . CONCLUSION In large hemodialysis patients , our study shows that dual dialyzers in parallel and series are equally effective at improving urea clearance without prolonging dialysis treatment times BACKGROUND Half of the dialysis population suffers from hyperphosphataemia , which is now recognized as a major factor of haemodialysis ( HD ) morbidity and mortality . Current control is focussed on reducing dietary phosphate intake and diminishing absorption using phosphate binders , whereas control and quantification of phosphate removal by HD is undervalued . The aim of this prospect i ve study was to develop a simple , bedside formula to estimate dialytic phosphate removal in stable HD patients . METHODS This was a prospect i ve , r and omized trial . Phosphate and urea elimination were assessed in a representative group of patients at two dialysis centres using r and omly different dialysers ( 1.3 - 2.4 m(2 ) ) . Quantification was performed by partial dialysate collection , concentration measurements in blood and effluent dialysate spot sample s , and Kt/V(urea ) during st and ard high-flux HD . Multiple linear regression analyses were used in 77 % of all data sets to generate an equation to predict phosphate removal . The formula was vali date d in the remaining 23 % of data sets , in the same group of patients using a large capillary filter , and in diabetic patients treated with a small dialyser at different blood flows ( 200 , 250 , and 300 ml/min ) . RESULTS A formula allowing quantification of phosphate removal within one HD session was developed in 18 of 74 patients during 41 treatments ( 137 out of 177 data sets ) and was determined as : M(PO4pred)=0.1 t -17 + 50c(ds60)+11c(b60 ) , where t is treatment time in min , c(ds60 ) and c(b60 ) are phosphate concentrations in dialysate and plasma measured 60 min into HD in mmol/l , and M(PO4pred ) is estimated phosphate removed in mmol . The precision was remarkable ( r(2)=0.92 - 0.94 ) . The comparison of phosphate and Kt/V(urea ) showed a significant association ( r(2)=0.28 ) , albeit with remarkable scatter . CONCLUSIONS We present the first approach to quantify phosphate removal during high-flux HD by a bedside formula . Only 28 % of the variation in phosphate removal was explained by Kt/V(urea ) . It appears that other factors not adequately accounted for by Kt/V(urea ) affect phosphate removal . Therefore , we propose an individual control and quantification of phosphate removal in HD Dialysis is measured as Kt/V , which scales the dose ( Kt ) to body water content ( V ) . Scaling dialysis dose to body surface area ( S(dub ) ) has been advocated , but the implication s of such rescaling have not been examined . We developed a method of rescaling measured Kt/V to S(dub ) and studied the effect of such alternative scaling on the minimum adequacy values that might then be applied in male and female patients of varying body size . We examined anthropometric estimates of V and S ( Watson vs. Dubois estimates ) in 1765 patients enrolled in the HEMO study after excluding patients with amputations . An S-normalized target stdKt/V was defined , and an adequacy ratio ( R ) was computed for each patient as R = D/N where D = delivered stdKt/V ( calculated using the Gotch-Leypoldt equation for stdKt/V ) and N = the S-normalized minimum target value . In the HEMO data set , we determined the extent to which baseline ( prer and omization ) stdKt/V values would have exceeded such an S-based minimum target stdKt/V. The median V(wat):S(dub ) ratios were significantly higher in men ( 21.34 ) than in women ( 18.50 ) . The average of these ( 20 ) was used to normalize the current suggested minimally adequate value ( stdKt/V > or = 2.0/week ) to the S-normalized target value ( stdKt/S > or = 40 L/M(2 ) ) , assuming that average modeled V = average anthropometric V. To achieve this S-normalized target , the required single-pool ( sp ) Kt/V was always higher in women than in men at any level of body size . For small patients ( V(wat ) = 25L ) , required stdKt/V values were 2.05 and 2.21/week for men and women , respectively , corresponding to spKt/V values of 1.31 and 1.52/session . On the other h and , large ( V(wat ) = 50L ) male patients would need spKt/V values of only 1.0/session . Prer and omization baseline dialysis sessions in the HEMO study were found to meet such a new S-based st and ard in almost all ( 766/773 ) men and in 885/992 women . An analysis of scaling dose to anthropometrically estimated liver size ( L ) showed similar gender ratios for V(wat):L and V(wat):S(dub ) , providing a potential physiologic explanation underpinning S-based scaling . S-based scaling of the dialysis dose would require considerably higher doses in small patients and in women , and would allow somewhat lower doses in larger male patients . Current dialysis practice would largely meet such an S-based adequacy st and ard if the dose were normalized to a V(wat):S(dub ) ratio of 20 BACKGROUND Using st and ard hemodialysis regimens , overweight patients often do not reach Kidney Disease Outcomes Quality Initiatives ( KDOQI ) Kt/V targets , and this has been associated with lower health-related quality of life ( HRQL ) . Whether increasing dialysis adequacy in large patients not achieving KDOQI targets improves HRQL is unknown . STUDY DESIGN R and omized blinded crossover study . SETTING & PARTICIPANTS Overweight ( > 80 kg ) underdialyzed patients from 6 dialysis units in 2 Canadian dialysis programs . INTERVENTIONS Six-week treatment periods with a st and ard dialysis regimen ( 4 hours 3 times weekly ) and 3 augmented regimens : 4.5 hours of hemodialysis , 4 hours of hemodialysis with increased dialysate flow , and 4 hours of hemodialysis with 2 dialyzers in parallel . OUTCOMES & MEASUREMENTS The End-Stage Renal Disease Symptom domain of the Kidney Disease Quality -of-Life Short-Form question naire ( primary outcome ) and the Health Utilities Index Mark 2 ( secondary outcome ) . RESULTS We enrolled 18 patients ( mean weight , 109.7 + /- 16.2 [ SD ] kg ) ; 12 completed all 4 regimens . Mean Kt/Vs during the study were 1.27 ( 95 % confidence interval [ CI ] , 1.19 to 1.35 ) , 1.41 ( 95 % CI , 1.32 to 1.50 ) , 1.31 ( 95 % CI , 1.22 to 1.39 ) , and 1.41 ( 95 % CI , 1.33 to 1.49 ) for patients receiving st and ard dialysis , 4.5 hours of hemodialysis , hemodialysis with increased dialysate flow , and hemodialysis with 2 dialyzers , respectively . Kidney Disease Quality -of-Life End-Stage Renal Disease Symptom domain and Health Utilities Index Mark 2 scores were 75.9 ( 95 % CI , 70.7 to 81.2 ) and 0.69 ( 95 % CI , 0.56 to 0.81 ) for patients receiving st and ard dialysis , respectively . These did not differ when patients received the 3 augmented dialysis regimens ( P = 0.2 and P = 0.5 , respectively ) . LIMITATIONS Small sample size and inability to fully blind patients to the treatment they were receiving . CONCLUSION Improving hemodialysis adequacy for large underdialyzed patients did not lead to improved HRQL . Our findings suggest that augmentation of the dialysis regimen is not required for these patients in the absence of overt uremic symptoms BACKGROUND Muscle cramp is a common complication of haemodialysis . The exact mechanism of this complication is still unknown . Many approaches have been used to relieve the muscle cramping but have had variable Output:	None of the studies defined adequacy of dialysis as a patient relevant outcome such as survival or quality of life . Patients had a substantially different underst and ing of the construct dialysis adequacy than the biochemical interpretation reported in the literature . Being alive , time spent while being on dialysis , fatigue and friendliness of staff were the most prominent themes that patients linked to the construct of dialysis adequacy . Conclusion Adequacy of dialysis as reported in the literature refers to biochemical outcome measures , most of which are not related with patient relevant outcomes . For patients , adequate dialysis is a dialysis that enables them to spend as much quality time in their life as possible
MS2627	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Health statistics routinely show higher morbidity and health services use for women , while mortality rates are higher for men . This analysis empirically identifies reasons for women 's poorer health . It is based on retrospective ( interview ) and prospect i ve ( health diaries ) data from the Health In Detroit Study . Three kinds of risk factors , which may help explain females ' excess , are considered : acquired risks , psychosocial aspects , and health-reporting behavior . Men and women differ markedly in acquired risks : smoking and job hazards are higher for men , but inactivity , nonemployment , stress , and many other factors are higher for women . Psychosocial aspects predispose women to more illness and health care . Women also had keener interest in the survey . When all of the risk factors are controlled , the morbidity gap narrows considerably . In fact , indicators of general and chronic health reverse to reveal higher morbidity for men . Similarly , females ' excesses for therapeutic care ( short- and long-term disability , medical visits , lay consultation , drug use ) diminish when risks and morbidity level are controlled . They actually reverse to a male excess for disability and medical care . Though most of the unveiled male excesses are statistically nonsignificant , their pattern allows a reasonable interpretation . Our results are closely compatible with recent analyses of sex mortality differences in several California sites , which could not eliminate men 's mortality excess by controlling for social factors . In conclusion , contemporary women 's poorer health profile stems largely from their roles and stress ( acquired risks ) , and to a smaller degree from their health attitudes . When social factors are taken into account , health data suggest a disadvantage for men , and mortality data maintain men 's disadvantage . Do the reasons lie in biology R. Lorraine Collins State University of New York at Stony Brook George A. Parks and G. Alan Marlatt University of Washington Two studies were conducted to assess variables related to the social determinants of alcohol consumption . In Study 1 , moderate- and heavy-drinking male under- graduates were paired with confederates who behaved in a sociable or unsociable manner while modeling either light or heavy consumption . Modeling occurred in the sociable conditions but not in the unsociable conditions , where subjects tended to drink heavily . In Study 2 , a similar group of subjects was exposed to one of three social status conditions crossed with light versus heavy consumption . The results indicated a modeling effect in all social status conditions . These studies provide further support for the existence of a modeling effect that can be disrupted by a lack of rapport between drinking partners . This latter finding has implication s for the etiology of problem drinking because it suggests that increased alcohol consumption may serve as a strategy for coping with aversive social interactions . Initial research on the effect of modeled consumption rates on social drinking ( Caudill & Marlatt , 1975 ) suggested that heavy-drink- ing men tended to match the consumption of their drinking partner whether his con- sumption was heavy or light . Subsequent examinations of this phenomenon replicated these findings in laboratory analogue drinking tasks such as the taste-rating task ( Cooper , Waterhouse , & Sobell , 1979 ; Hendricks , So- bell , & Cooper , 1978 ; Lied & Marlatt , 1979 ; Watson & Sobell , 1982 ) , natural bar setting s ( Reid , 1978 ) , and seminaturalistic bar setting s ( Caudill & Lipscomb , 1980 ) . Much of the research concerning the mod- eling of alcohol consumption has focused on manipulating characteristics of the model , including the nature of the social interaction between the model and the subject . The effects of manipulating social interaction are unclear . In the Caudill and Marlatt study , model 's drinking rate ( light vs. heavy ) and Output:	The main findings were : 1 ) conformity to norms associated with traditional masculine role ( dominance , womanising , aggressiveness , risk behaviours ) is related to greater alcohol use ; 2 ) conformity to norms associated with traditional feminine role ( interest in home life and family care ) is related with lower alcohol use . These findings provide evidence of the relationship between dimensions associated with gender and drinking .
MS2628	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Physical fitness is inversely related to mortality in the general population and in subjects with type 2 diabetes . Here , we present data concerning the relationship between changes in physical fitness and modifiable cardiovascular risk factors in subjects with type 2 diabetes from the Italian Diabetes and Exercise Study . RESEARCH DESIGN AND METHODS Sedentary patients with type 2 diabetes ( n = 606 ) were enrolled in 22 outpatient diabetes clinics and r and omized to twice-a-week supervised aerobic and resistance training plus exercise counseling versus counseling alone for 12 months . Baseline to end-of- study changes in cardiorespiratory fitness , strength , and flexibility , as assessed by Vo2max estimation , a 5–8 maximal repetition test , and a hip/trunk flexibility test , respectively , were calculated in the whole cohort , and multiple regression analyses were applied to assess the relationship with cardiovascular risk factors . RESULTS Changes in Vo2max , upper and lower body strength , and flexibility were significantly associated with the variation in the volume of physical activity , HbA1c , BMI , waist circumference , high-sensitivity C-reactive protein ( hs-CRP ) , coronary heart disease ( CHD ) risk score , and inversely , HDL cholesterol . Changes in fitness predicted improvements in HbA1c , waist circumference , HDL cholesterol , hs-CRP , and CHD risk score , independent of study arm , BMI , and in case of strength , also waist circumference . CONCLUSIONS Physical activity/exercise-induced increases in fitness , particularly muscular , predict improvements in cardiovascular risk factors in subjects with type 2 diabetes independently of weight loss , thus indicating the need for targeting fitness in these individuals , particularly in subjects who struggle to lose weight Objective : We have previously reported insignificant changes in HbA1c after exercise in patients with both type 2 diabetes and coronary artery disease . In this study , we investigated the effect of exercise on endothelial function and possible associations between changes in endothelial function and HbA1c . Methods : Patients with type 2 diabetes and coronary artery disease ( n = 137 ) were r and omised to 12 months exercise or st and ard follow-up . Endothelial function was assessed by circulating biomarkers ( E-selectin , intercellular adhesion molecule-1 , vascular cell adhesion molecule-1 , von Willebr and factor , tissue plasminogen activator antigen , asymmetric dimethylarginine and L-arginine/asymmetric dimethylarginine ratio ) . Differences between the r and omised groups were analysed by analysis of covariance and correlations by Spearman ’s rho or Pearson ’s correlation . Results : No effect of exercise on endothelial function was demonstrated . The changes in HbA1c in the exercise group correlated with changes in E-selectin ( r = 0.56 , p < 0.001 ) , intercellular adhesion molecule-1 ( r = 0.27 , p = 0.052 ) , vascular cell adhesion molecule-1 ( r = 0.32 , p = 0.022 ) and tissue plasminogen activator antigen ( r = 0.35 , p = 0.011 ) . HbA1c decreased significantly more in patients with versus without a concomitant reduction in E-selectin ( p = 0.002 ) , intercellular adhesion molecule-1 ( p = 0.011 ) , vascular cell adhesion molecule-1 ( p = 0.028 ) and tissue plasminogen activator antigen ( p = 0.009 ) . Conclusion : Exercise did not affect biomarkers of endothelial function in patients with both type 2 diabetes and coronary artery disease . However , changes in biomarkers of endothelial activation correlated with changes in HbA1c , and reduced endothelial activation was associated with improved HbA1c after exercise Importance It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes . Objective To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with st and ard care and , secondarily , leads to a reduction in glucose-lowering medication in participants with type 2 diabetes . Design , Setting , and Participants R and omized , assessor-blinded , single-center study within Region Zeal and and the Capital Region of Denmark ( April 2015-August 2016 ) . Ninety-eight adult participants with non – insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included . Participants were r and omly assigned ( 2:1 ; stratified by sex ) to the lifestyle group ( n = 64 ) or the st and ard care group ( n = 34 ) . Interventions All participants received st and ard care with individual counseling and st and ardized , blinded , target-driven medical therapy . Additionally , the lifestyle intervention included 5 to 6 weekly aerobic training sessions ( duration 30 - 60 minutes ) , of which 2 to 3 sessions were combined with resistance training . The lifestyle participants received dietary plans aim ing for a body mass index of 25 or less . Participants were followed up for 12 months . Main Outcomes and Measures Primary outcome was change in hemoglobin A1c ( HbA1c ) from baseline to 12-month follow-up , and equivalence was prespecified by a CI margin of ±0.4 % based on the intention-to-treat population . Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication . Results Among 98 r and omized participants ( mean age , 54.6 years [ SD , 8.9 ] ; women , 47 [ 48 % ] ; mean baseline HbA1c , 6.7 % ) , 93 participants completed the trial . From baseline to 12-month follow-up , the mean HbA1c level changed from 6.65 % to 6.34 % in the lifestyle group and from 6.74 % to 6.66 % in the st and ard care group ( mean between-group difference in change of −0.26 % [ 95 % CI , −0.52 % to −0.01 % ] ) , not meeting the criteria for equivalence ( P = .15 ) . Reduction in glucose-lowering medications occurred in 47 participants ( 73.5 % ) in the lifestyle group and 9 participants ( 26.4 % ) in the st and ard care group ( difference , 47.1 percentage points [ 95 % CI , 28.6 - 65.3 ] ) . There were 32 adverse events ( most commonly musculoskeletal pain or discomfort and mild hypoglycemia ) in the lifestyle group and 5 in the st and ard care group . Conclusions and Relevance Among adults with type 2 diabetes diagnosed for less than 10 years , a lifestyle intervention compared with st and ard care result ed in a change in glycemic control that did not reach the criterion for equivalence , but was in a direction consistent with benefit . Further research is needed to assess superiority , as well as generalizability and durability of findings . Trial Registration clinical trials.gov Identifier : OBJECTIVE To investigate the associations between changes in body composition and fitness after exercise training and changes in hemoglobin A1c ( HbA1c ) in individuals with type 2 diabetes . RESEARCH DESIGN AND METHODS Participants ( n = 201 ) were r and omized to aerobic , resistance , or combined training for 9 months . HbA1c , waist circumference , total and trunk fat mass , appendicular fat mass , lean body mass , isokinetic leg muscle strength , peak O2 uptake , and estimated METs were assessed at baseline and follow-up . Change in HbA1c was evaluated across quartiles of change in body composition and fitness . RESULTS Change in HbA1c was associated with changes in body weight ( r = 0.13 , P = 0.052 ) , waist circumference ( r = 0.17 , P = 0.013 ) , trunk fat mass ( r = 0.19 , P = 0.005 ) , and estimated METs ( r = −0.16 , P = 0.023 ) . There was a trend in change in HbA1c across quartiles of waist circumference ( P = 0.011 ) , trunk fat mass ( P = 0.020 ) , and estimated METs ( P = 0.011 ) . Participants with increased estimated METs and reduced trunk fat mass had greater odds of having reduced HbA1c after training ( 3.48 , 1.46–8.31 ) . Finally , participants with increased estimated METs and reduced waist circumference were 2.81 ( 1.13–6.98 ) times more likely to have reduced HbA1c and type 2 diabetes medication use than those without improved fitness and central adiposity . CONCLUSIONS In patients with type 2 diabetes , a reduction in central adiposity and increase in fitness were the most prominent predictors of the change in HbA1c in response to exercise training CONTEXT Exercise guidelines for individuals with diabetes include both aerobic and resistance training although few studies have directly examined this exercise combination . OBJECTIVE To examine the benefits of aerobic training alone , resistance training alone , and a combination of both on hemoglobin A(1c ) ( HbA(1c ) ) in individuals with type 2 diabetes . DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled trial in which 262 sedentary men and women in Louisiana with type 2 diabetes and HbA(1c ) levels of 6.5 % or higher were enrolled in the 9-month exercise program between April 2007 and August 2009 . INTERVENTION Forty-one participants were assigned to the nonexercise control group , 73 to resistance training 3 days a week , 72 to aerobic exercise in which they expended 12 kcal/kg per week ; and 76 to combined aerobic and resistance training in which they expended 10 kcal/kg per week and engaged in resistance training twice a week . Main Outcome Change in HbA(1c ) level . Secondary outcomes included measures of anthropometry and fitness . RESULTS The study included 63.0 % women and 47.3 % nonwhite participants who were a mean ( SD ) age of 55.8 years ( 8.7 years ) with a baseline HbA(1c ) level of 7.7 % ( 1.0 % ) . Compared with the control group , the absolute mean change in HbA(1c ) in the combination training exercise group was -0.34 % ( 95 % confidence interval [ CI ] , -0.64 % to -0.03 % ; P = .03 ) . The mean changes in HbA(1c ) were not statistically significant in either the resistance training ( -0.16 % ; 95 % CI , -0.46 % to 0.15 % ; P = .32 ) or the aerobic ( -0.24 % ; 95 % CI , -0.55 % to 0.07 % ; P = .14 ) groups compared with the control group . Only the combination exercise group improved maximum oxygen consumption ( mean , 1.0 mL/kg per min ; 95 % CI , 0.5 - 1.5 , P < .05 ) compared with the control group . All exercise groups reduced waist circumference from -1.9 to -2.8 cm compared with the control group . The resistance training group lost a mean of -1.4 kg fat mass ( 95 % CI , -2.0 to -0.7 kg ; P < .05 ) and combination training group lost a mean of -1.7 ( -2.3 to -1.1 kg ; P < .05 ) compared with the control group . CONCLUSIONS Among patients with type 2 diabetes mellitus , a combination of aerobic and resistance training compared with the nonexercise control group improved HbA(1c ) levels . This was not achieved by aerobic or resistance training alone . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00458133 Aim /hypothesisIn people with type 2 diabetes , exercise improves glucose control ( as reflected in HbA1c ) and physical fitness , but it is not clear to what extent these exercise-induced improvements are correlated with one another . We hypothesised that reductions in HbA1c would be related : ( 1 ) to increases in aerobic fitness and strength respectively in patients performing aerobic training or resistance training ; and ( 2 ) to changes in strength and aerobic fitness in patients performing aerobic and resistance training . Methods We r and omly allocated 251 type 2 diabetes patients to aerobic , resistance , or aerobic plus resistance training , or to a sedentary control group . Peak oxygen consumption ( $ $ \mathop {V}\limits^\cdot { { \text{O}}_{\text{2 peak } } } $ $ ) , workload , treadmill time and ventilatory threshold measurements from maximal treadmill exercise testing were measured at baseline and 6 months . Muscular strength was measured as the maximum weight that could be lifted eight times on the leg press , bench press and seated row exercises . Results With aerobic training , significant associations were found between changes in both $ $ \mathop {V}\limits^\cdot { { \text{O}}_{\text{2 peak } } } $ $ ( p = 0.040 ) and workload ( p = 0.022 ) , and changes in HbA1c . With combined training , improvements in $ $ \mathop {V}\limits^\cdot { { \text{O}}_{\text{2 Output:	We conclude that exercise training is associated with reductions of HbA1c in patients with DM2 . Thus , it can be a complementary tool in the management of these patients
MS2629	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Chromoendoscopy can accurately differentiate neoplastic from nonneoplastic polyps in the colon . Narrow b and imaging ( NBI ) has been described as " electronic chromoendoscopy , " but it is unclear whether pit patterns seen with chromoendoscopy are identical to those with NBI . OBJECTIVE Pilot study to compare features of diminutive polyps assessed with magnification NBI and chromoendoscopy . DESIGN Prospect i ve polyp series . SETTING Single tertiary referral center in the United Kingdom . PATIENTS Twenty patients seen for routine colonoscopy . INTERVENTION Digital images of each polyp recorded with NBI and chromoendoscopy were subsequently assessed as single images in a r and om order and as paired polyp images by experienced European- and Japanese-trained endoscopists . MAIN OUTCOME MEASUREMENTS Pit pattern ( Kudo classification ) ; vascular pattern intensity ( weak , normal , strong ) ; predicted histology ; pit pattern and vessel network clarity ( scale 1 - 3 , 1 poor , 3 excellent ) . RESULTS A total of 33 polyps < or=6 mm were assessed . Chromoendoscopic and NBI pit patterns were different for 12 and 20 of 33 polyps ( Japanese and European , respectively ) , combined kappa 0.23 , P < .001 compared with published intraobsever variation . Sensitivity , specificity , and accuracy for neoplasia were comparable for chromoendoscopic and NBI pit patterns and vascular pattern intensity for both observers . Vessel network clarity was better with NBI , P < .001 ( both ) , as was pit pattern clarity , P = .04 ( European ) . LIMITATIONS Small sample size ; pilot study . CONCLUSIONS Pit patterns were not always identical with NBI and chromoendoscopy . The Kudo classification may need to be modified and revali date d before it can be used with confidence with NBI . Vascular pattern intensity , a simple color change , appears as accurate as pit pattern Context How often does colonoscopy miss adenomas ? Contribution During a multicenter screening trial , experienced colonoscopists performed same-day optical ( OC ) and virtual colonoscopy ( VC ) on 1233 asymptomatic adults . Optical colonoscopy performed without knowledge of the VC findings missed 55 of 511 polyps ; 21 of these polyps were adenomas measuring 6 mm or greater . Adenomas missed by OC were usually on the proximal side of a fold or near the anal verge . Virtual colonoscopy missed 14 % of the adenomas that measured 6 mm or greater that were de-tected by OC . Implication s Neither OC nor VC is a perfect test : Each misses 10 % to 14 % of adenomas that measure 6 mm or greater . The Editors Optical colonoscopy ( OC ) is widely accepted as the gold st and ard for detecting colorectal neoplasia ( 1 , 2 ) . However , even in the most experienced h and s , this skilled examination is underst and ably not infallible . Retrospective analysis has suggested that the OC miss rate for adenomas 10 mm or greater is approximately 10 % ( 3 ) . More recently , prospect i ve back-to-back or t and em colonoscopy studies have reported miss rates for 10-mm adenomas ranging from 0 % to 6 % ( 4 , 5 ) . However , in addition to evaluating relatively small population s of patients with a high prevalence of polyps , a notable weakness common to these studies was that they used OC as its own reference st and ard . In a large , prospect i ve , multicenter trial that was primarily intended to evaluate the performance of virtual colonoscopy ( VC ) in asymptomatic adults ( 6 ) , we also had a unique opportunity to evaluate the adenoma miss rate on OC by segmentally unblinding the results from same-day VC . By using a reference st and ard other than OC itself for comparison , we could uncover lesions that may be systematic ally missed on repeated colonoscopies . These data not only provide novel insight into OC miss rates but also indicate the relative blind spots where more attention could be focused . Methods Study Design The institutional review boards at all 3 participating medical centers approved the study protocol for same-day VC and OC , and all patients provided written informed consent . We recruited asymptomatic adults who were referred for colorectal cancer screening . Exclusion criteria were a positive stool guiaic test result or iron deficiency anemia within the past 6 months ; rectal bleeding , hematochezia , or unintentional weight loss of more than 10 pounds within the past 12 months ; OC within the past 10 years or barium enema within the past 5 years ; personal history of adenomatous polyps , colorectal cancer , or inflammatory bowel disease ; and family history of familial adenomatous polyposis or nonpolyposis cancer syndromes . Between May 2002 and June 2003 , 1253 asymptomatic adults enrolled in the study . Eight patients were excluded because of failure to reach the cecum at OC , 6 patients were excluded because of inadequate colonic preparation , and another 6 patients were excluded because of computed tomography ( CT ) system failure . The final study group comprised 1233 asymptomatic adults ( 728 men and 505 women ; mean age , 57.8 years ) who successfully completed same-day VC and OC . Study participants underwent colonic preparation with oral intake of 90 mL of phospho-soda and 10 mg of bisacodyl . To opacify residual colonic fluid and stool for VC examination , patients also consumed dilute oral contrast as previously described ( 7 ) . Our CT protocol and VC technique have also been detailed previously ( 6 ) . To briefly summarize , we obtained supine and prone CT acquisitions on multidetector scanners after patient-controlled rectal insufflation of room air . One of 6 trained radiologists interpreted VC studies by using a commercially available CT colonography system ( Viatronix V3D-Colon , version 1.2 , Viatronix , Inc. , Stony Brook , New York ) . We used the 3-dimensional endoluminal fly-through view primarily for detecting polyps and 2-dimensional images for confirmation and problem solving . We measured polyps on the 3-dimensional view and recorded them by segment ( cecum , ascending colon , hepatic flexure , transverse colon , splenic flexure , descending colon , sigmoid colon , or rectum ) . We defined the proximal colon as including the cecum to the splenic flexure . We prospect ively rated diagnostic confidence for each detected lesion on a 3-point scale ( most certain , intermediate , and least certain ) . One of 17 experienced colonoscopists performed OC immediately after VC interpretation by using st and ard commercial video colonoscopes ( Olympus , Inc. , Melville , New York ) . The colonoscope was advanced to the cecum and then sequentially withdrawn into more distal segments for polyp detection . The colonoscopist measured polyps by using a calibrated linear probe , which is more accurate than either visual or biopsy forceps estimation ( 8) . Our polyp-matching algorithm requires VC and OC agreement according to size ( within a 50 % margin of error ) and location ( within the same or adjacent segment ) . After the colonoscopist evaluated a given segment , a study nurse unblinded the VC results for the previous segment . For any suspected polyp seen on VC that measured 5 mm or greater but was not seen on the initial blinded OC , the colonoscopist closely reexamined that segment and could review the VC images for guidance . We sent all retrieved polyps for histologic examination . For all cases in which a colorectal neoplasm measuring 6 mm or greater was found on second-look OC , we retrospectively review ed both the VC and OC images . We recorded polyp characteristics , such as size , morphologic characteristic ( sessile , pedunculated , or flat ) , and location on VC . If the polyp was situated on a colonic fold on VC , we further subcategorized it as being located on the back ( proximal ) side , front ( distal ) side , or edge of the fold . We analyzed both supine and prone VC sets for all cases . The primary reason that diminutive polyps measuring 5 mm at VC were included for potential unblinding at OC was that , given the relative error in polyp measurement , such polyps found on second-look OC might , in fact , measure 6 mm or greater . This allows for more accurate assessment of the OC miss rate at the 6-mm threshold . We did not include unblinded polyps that measured 5 mm or less on both VC and OC examinations in the final analysis . All study participants completed a detailed question naire on their personal and family medical history . For the purpose s of this study , particular attention was given to the question about previous abdominal or pelvic surgery , since adhesions could conceivably result in a more difficult colonoscopic examination . Statistical Analysis Prospect i ve OC performance was compared against the enhanced reference st and ard of second-look OC after segmental unblinding of VC results . We estimated exact binomial 95 % CIs for OC miss rates . We used the chi-square test to compare the frequency of previous abdominal surgery among patients with and without polyps missed at OC and also to compare the OC miss rates among the 3 medical centers . We calculated the 95 % CIs by using Stata software , version 7.0 for Windows ( Stata Corp. , College Station , Texas ) , and performed the chi-square tests by using SAS software , version 8.0 for Windows ( SAS Institute , Inc. , Cary , North Carolina ) . Role of the Funding Source The funding source had no role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results The performance characteristics of VC from this prospect i ve , multicenter screening trial , using OC as the reference st and ard , have been previously reported ( 6 ) . Our technique of segmental unblinding also allows for a separate assessment of OC by using the blinded VC results for comparison , which is the focus of this study . We identified 1310 polyps at OC in the 1233 asymptomatic adults ; 511 ( 39.0 % ) of these polyps measured 5 mm or greater ( Figure 1).Of these 511 polyps , 55 ( 10.8 % ) were found only on second-look OC after segmental unblinding of VC results . Twenty-four ( 43.6 % ) of the 55 unblinded lesions were nonadenomatous , including 16 hyperplastic polyps . Of the 31 missed neoplasms , 10 adenomas that measured only 5 mm were excluded from further analysis because of their diminutive size ( 9 ) . Including unblinded lesions , 554 adenomas were detected on OC in this screening sample ; 210 of these measured 6 mm or greater and 51 measured 10 mm or greater . Figure 1 . Polyp flowchart . In 20 patients ( 17 men and 3 women ; mean age , 58.2 years ) , 21 adenomas measuring 6 mm or greater ( range , 6 mm to 17 mm ; mean , 8.1 mm ) were found on OC only after the VC results were unblinded , which represent the lesions of primary interest for this study ( Table ) . The corresponding adenoma miss rate on prospect i ve OC examination was 10.0 % ( 95 % CI , 6.3 % to 14.9 % ) ( 21 of 210 adenomas ) at a 6-mm cutoff . The 20 patients with missed adenomas that measured 6 mm or greater represented only 1.6 % of the study sample ( 20 of 1233 patients ) but 11.9 % of patients with adenomas 6 mm or greater ( 20 of 168 patients ) . At 8-mm and 10-mm thresholds , the OC adenoma miss rates by polyp were 10.5 % ( CI , 5.2 % to 18.5 % ) ( 10 of 95 adenomas ) and 11.8 % ( CI , 4.4 % to 23.9 % ) ( 6 of 51 adenomas ) , respectively . The 10 patients with missed adenomas 8 mm or greater represented 12.2 % ( 10 of 82 patients ) of all patients with neoplasms of this size or greater ; the 6 patients with missed adenomas 8 mm or greater represented 12.5 % of all patients with neoplasms 10 mm or greater . Table . Characteristics of Neoplasms Missed at Prospect i ve Colonoscopic Evaluation Seventeen ( 81.0 % ) of the 21 unblinded neoplasms 6 mm or greater were tubular adenomas , 3 ( 14.3 % ) were tubulovillous adenomas , and 1 ( 4.8 % ) was an adenocarcinoma . Seven ( 33.3 % ) of the 21 unblinded polyps were classified as advanced lesions ( that is , size 10 mm or high- grade dysplasia , prominent villous component , or focus of malignancy ) . There were 15 sessile lesions , 4 pedunculated lesions , and 2 flat An important determinant in interpreting the results of colorectal polyp chemoprevention trials is the rate of polyps missed during colonscopic examination . We prospect ively examined 90 patients by t and em colonoscopy performed by two alternating examiners . In 69 ( 76.7 % ) patients , 221 neoplastic lesions were documented histologically . Of a total of 58 lesions detected in 31 patients , no neoplastic lesion greater than or equal to 10 mm in size was missed ; 16 % of diminutive ( less than or equal to 5 mm ) neop Output:	We could not find convincing evidence that NBI is significantly better than high definition WLC for the detection of patients with colorectal polyps , or colorectal adenomas . We found evidence that NBI might be better than st and ard definition WLC and equal to high definition WLC for detection the patients with colorectal polyps , or colorectal adenomas
MS2630	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND AND OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review Background Although several studies have reported positive effects of mindfulness-based stress reduction ( MBSR ) intervention on psychological well-being , it is not known whether these effects are attributable to a change in mindfulness . Purpose The aim of this study is to compare the effects of MBSR to a waiting-list control condition in a r and omized controlled trial while examining potentially mediating effects of mindfulness . Methods Forty women and 20 men from the community with symptoms of distress ( mean age 43.6 years , SD = 10.1 ) were r and omized into a group receiving MBSR or a waiting-list control group . Before and after the intervention period , question naires were completed on psychological well-being , quality of life , and mindfulness . Results Repeated measures multiple analysis of variance ( MANCOVAs ) showed that , compared with the control group , the intervention result ed in significantly stronger reductions of perceived stress ( p = 0.016 ) and vital exhaustion ( p = 0.001 ) and stronger elevations of positive affect ( p = 0.006 ) , quality of life ( p = .009 ) , as well as mindfulness ( p = 0.001 ) . When mindfulness was included as a covariate in the MANCOVA , the group effects on perceived stress and quality of life were reduced to non significance . Conclusion Increased mindfulness may , at least partially , mediate the positive effects of mindfulness-based stress reduction intervention Objective : The underlying changes in biological processes that are associated with reported changes in mental and physical health in response to meditation have not been systematic ally explored . We performed a r and omized , controlled study on the effects on brain and immune function of a well‐known and widely used 8‐week clinical training program in mindfulness meditation applied in a work environment with healthy employees . Methods : We measured brain electrical activity before and immediately after , and then 4 months after an 8‐week training program in mindfulness meditation . Twenty‐five subjects were tested in the meditation group . A wait‐list control group ( N = 16 ) was tested at the same points in time as the meditators . At the end of the 8‐week period , subjects in both groups were vaccinated with influenza vaccine . Results : We report for the first time significant increases in left‐sided anterior activation , a pattern previously associated with positive affect , in the meditators compared with the nonmeditators . We also found significant increases in antibody titers to influenza vaccine among subjects in the meditation compared with those in the wait‐list control group . Finally , the magnitude of increase in left‐sided activation predicted the magnitude of antibody titer rise to the vaccine . Conclusions : These findings demonstrate that a short program in mindfulness meditation produces demonstrable effects on brain and immune function . These findings suggest that meditation may change brain and immune function in positive ways and underscore the need for additional research OBJECTIVE To evaluate the efficacy of Qigong in rehabilitation for patients with burnout . DESIGN Prospect i ve , r and omized controlled trial . SUBJECTS Eighty-two patients ( 68 women and 14 men , mean age 44.3 ( st and ard deviation 9.1 ) years ) diagnosed with burnout . METHODS Basic care was offered to both the intervention and the control group . Patients in the intervention group received basic care and , in addition , performed Qigong twice a week for 12 weeks . Psychological variables , health-related quality of life , perceived relaxation and physical measurements were assessed at baseline and after the intervention period . RESULTS No significant difference in treatment efficacy between the groups was found by either intention-to-treat or per- protocol analyses . Both groups improved significantly over time , with reduced levels of burnout , fatigue , anxiety and depression , and increased dynamic balance and physical capacity . CONCLUSION In this study , a Qigong intervention twice a week for 12 weeks had no additional effect beyond basic care for patients with burnout Objective This study tests the hypothesis that stress reduction methods based on mindfulness meditation can positively influence the rate at which psoriasis clears in patients undergoing phototherapy or photochemotherapy treatment . Methods Thirty-seven patients with psoriasis about to undergo ultraviolet phototherapy ( UVB ) or photochemotherapy ( PUVA ) were r and omly assigned to one of two conditions : a mindfulness meditation-based stress reduction intervention guided by audiotaped instructions during light treatments , or a control condition consisting of the light treatments alone with no taped instructions . Psoriasis status was assessed in three ways : direct inspection by unblinded clinic nurses ; direct inspection by physicians blinded to the patient 's study condition ( tape or no-tape ) ; and blinded physician evaluation of photographs of psoriasis lesions . Four sequential indicators of skin status were monitored during the study : a First Response Point , a Turning Point , a Halfway Point , and a Clearing Point . Results Cox-proportional hazards regression analysis showed that subjects in the tape groups reached the Halfway Point ( p = .013 ) and the Clearing Point ( p = .033 ) significantly more rapidly than those in the no-tape condition , for both UVB and PUVA treatments . Conclusions A brief mindfulness meditation-based stress reduction intervention delivered by audiotape during ultraviolet light therapy can increase the rate of resolution of psoriatic lesions in patients with psoriasis CONTEXT Qigong is a traditional Chinese health practice believed to have special healing and recovery power . Little scientific documentation was found on qigong and its effectiveness , and no literature was found on qigong as a treatment of substance addiction . OBJECTIVE To explore the effectiveness of qigong therapy on detoxification of heroin addicts compared to medical and nonmedical treatment . DESIGN Participants were r and omly assigned to 1 of 3 groups : qigong treatment group ( n = 34 ) , medication group ( n = 26 ) , and no-treatment control group ( n = 26 ) . PARTICIPANTS Eighty-six male heroin addicts , aged 18 to 52 years , who met the substance-dependence criteria of the Diagnostic and Statistical Manual of Mental Disorders , Third Edition Revised , with a history of heroin use from .5 to 11 years . All were residents at a m and atory drug-treatment center in the People 's Republic of China . INTERVENTION The qigong group practice d Pan Gu qigong and received qi adjustments from a qigong master daily . The medication group received the detoxification drug lofexidine-HCl by a 10-day gradual reduction method . The control group received only basic care and medications to treat severe withdrawal symptoms . MEASURES Urine morphine test , electrocardiogram , Hamilton Anxiety Scale , and a withdrawal-symptom evaluation scale were applied before and during the 10-day intervention . RESULTS Reduction of withdrawal symptoms in the qigong group occurred more rapidly than in the other groups . From day 1 , the qigong group had significantly lower mean symptom scores than did the other groups ( P < .01 ) . Both the qigong and medication groups had much lower anxiety scores than did the control group ( P<.01 ) , and the qigong group had significantly lower anxiety scores than did the medication group ( P<.01 ) . All subjects had a positive response to the urine morphine test before treatment . Fifty percent of the qigong group had negative urine tests on day 3 , compared to 23 % in the control group and 8 % in the medication group ( P < .01 ) . By day 5 of treatment , all subjects in the qigong group had negative urine tests , compared to day 9 for the medication group and day 11 for the control group . CONCLUSIONS Results suggest that qigong may be an effective alternative for heroin detoxification without side effects , though we can not completely eliminate the possibility of the placebo effect from the current study Background There is increasing recognition of mindfulness and mindfulness training as a way to decrease stress and increase psychological functioning . Purpose The aims of this study were to examine the effects of mindfulness stress reduction training on perceived stress and psychological well-being and to examine if changes in mindfulness mediate intervention effects on these outcomes . Methods Seventy women and one man with a previous cancer diagnosis ( mean age 51.8 years , st and ard deviation = 9.86 ) were r and omized into an intervention group or a wait-list control group . The intervention consisted of an 8-week mindfulness training course . Results Compared to participants in the control group , participants in the mindfulness training group had significantly decreased perceived stress and posttraumatic avoidance symptoms and increased positive states of mind . Those who participated in the intervention reported a significant increase in scores on the five-facet mindfulness question naire ( FFMQ ) when compared to controls . The increase in FFMQ score mediated the effects of the intervention on perceived stress , posttraumatic avoidance symptoms , and positive states of mind . Conclusions This study indicates that the improvements in psychological well-being result ing from mindfulness stress reduction training can potentially be explained by increased levels of mindfulness as measured with the FFMQ . The importance of these findings for future research in the field of mindfulness is discussed BACKGROUND Psychological distress contributes to the development of hypertension in young adults . This trial assessed the effects of a mind-body intervention on blood pressure ( BP ) , psychological distress , and coping in college students . METHODS This was a r and omized controlled trial ( RCT ) of 298 university students r and omly allocated to either the Transcendental Meditation ( TM ) program or wait-list control . At baseline and after 3 months , BP , psychological distress , and coping ability were assessed . A subgroup of 159 subjects at risk for hypertension was analyzed similarly . RESULTS Changes in systolic BP (SBP)/diastolic BP ( DBP ) for the overall sample were -2.0/-1.2 mm Hg for the TM group compared to + 0.4/+0.5 mm Hg for controls ( P = 0.15 , P = 0.15 , respectively ) . Changes in SBP/DBP for the hypertension risk subgroup were -5.0/-2.8 mm Hg for the TM group compared to + 1.3/+1.2 mm Hg for controls ( P = 0.014 , P = 0.028 , respectively ) . Significant improvements were found in total psychological distress , anxiety , depression , anger/hostility , and coping ( P values < 0.05 ) . Changes in psychological distress and coping correlated with changes in SBP ( P values < 0.05 ) and DBP ( P values < 0.08 ) . CONCLUSIONS This is the first RCT to demonstrate that a selected mind-body intervention , the TM program , decreased BP in association with decreased psychological distress , and increased coping in young adults at risk for hypertension . This mind-body program may reduce the risk for future development of hypertension in young adults OBJECTIVE The aim of this study was to investigate the potential of mindfulness-based stress reduction ( MBSR ) as a treatment for chronic primary insomnia . DESIGN A r and omized controlled trial was conducted . SETTING The study was conducted at a university health center . PATIENTS Thirty adults with primary chronic insomnia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders , Text Revision , 4th Edition were r and omized 2:1 to MBSR or pharmacotherapy ( PCT ) . INTERVENTIONS Mindfulness-based stress reduction , a program of mindfulness meditation training consisting of eight weekly 2.5 hour classes and a daylong retreat , was provided , with ongoing home meditation practice expectations during three-month follow-up ; PCT , consisting of three milligrams of eszopiclone ( LUNESTA ) nightly for eight weeks , followed by three months of use as needed . A 10-minute sleep hygiene presentation was included in both interventions . MAIN OUTCOMES The Insomnia Severity Index ( ISI ) , Pittsburgh Sleep Quality Index ( PSQI ) , sleep diaries , and wrist actigraphy were collected pretreatment , posttreatment ( eight weeks ) , and at five months ( self-reports only ) . RESULTS Between baseline and eight weeks , sleep onset latency ( SOL ) measured by actigraphy decreased 8.9 minutes in the MBSR arm ( P < .05 ) . Large , significant improvements were found on the ISI , PSQI , and diary-measured total sleep time , SOL , and sleep efficiency ( P < .01 , all ) from baseline to five-month follow-up in the M Output:	This review demonstrates some efficacy of meditative therapies in reducing anxiety symptoms , which has important clinical implication s for applying meditative techniques in treating anxiety . However , most studies measured only improvement in anxiety symptoms , but not anxiety disorders as clinical ly diagnosed
MS2631	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Patient nonadherence is common for the st and ard mental health treatments in primary care : antidepressants and referrals to specialty mental health treatment . This is one of few studies to prospect ively identify predictors of nonadherence . METHODS We observed 95 veterans attending an internal medicine clinic prescribed antidepressant medication or referred to mental health treatment . We collected information on sociodemographic factors , health beliefs , preferences about treatment , past experiences , and treatment knowledge . RESULTS At 1 month , medication adherence was greater when patients experienced previous pharmacy trouble and traveled for less than 30 minutes to reach the clinic . Appointment attendance improved when patients were ready for treatment , perceived benefits , and saw their physician as collaborative . At 6 months , medication adherence was greater when patients reported a preference for medicine treatment , traveled for less than 30 minutes , and perceived greater benefits . Fewer negative effects from previous mental health treatment improved adherence to appointments . In multivariate analyses examining adherence to all treatments , greater readiness for treatment predicted 1-month adherence , whereas being unmarried and seeing the physician as more collaborative improved 6-month adherence . CONCLUSIONS Adherence to antidepressant medications and to mental health referrals should be examined separately . A brief initial assessment for nonadherence risk factors may identify persons for targeted adherence promoting interventions BACKGROUND Many patients recovering from a first psychotic episode will discontinue medication against medical advice , even before a 1-year treatment course is completed . Factors associated with treatment adherence in patients with chronic schizophrenia include beliefs about severity of illness and need for treatment , treatment with typical versus atypical antipsychotic and medication side effects . METHOD In this 2-year prospect i ve study of 254 patients recovering from a first episode of schizophrenia , schizophreniform , or schizoaffective disorder we examined the relationship between antipsychotic medication non-adherence and patient beliefs about : need for treatment , antipsychotic medication benefits , and negative aspects of antipsychotic medication treatment . We also examined the relationship between medication non-adherence and treatment with either haloperidol or olanzapine , and objective measures of symptom response and side effects . RESULTS The likelihood of becoming medication non-adherent for 1 week or longer was greater in subjects whose belief in need for treatment was less ( HR=1.75 , 95 % CI 1.16 , 2.65 , p=0.0077 ) or who believed medications were of low benefit ( HR=2.88 , 95 CI 1.79 - 4.65 , p<0.0001 ) . Subjects r and omized to haloperidol were more likely to become medication non-adherent for > or=1 week than subjects r and omized to olanzapine ( HR-1.51 , 95 % CI 1.01 , 2.27 , p=0.045 ) . CONCLUSION Beliefs about need for treatment and the benefits of antipsychotic medication may be intervention targets to improve likelihood of long-term medication adherence in patients recovering from a first episode of schizophrenia , schizoaffective , or schizophreniform disorder Objective : To evaluate the efficacy of two community‐based programs that combined antipsychotic medication , family interventions and social skills training Dropout from prophylactic neuroleptic treatment is one major reason for relapse in schizophrenia patients . There is a lack of prospect i ve studies on factors that predict medication adherence . We investigated factors suspected to predict dropout from continuous neuroleptic treatment in a 2-year prospect i ve study involving 122 out patients with a DSM-III-R diagnosis of schizophrenia . Forty-two ( 34.4 % ) were classified as patient-related dropouts . No significant difference between compliant patients and dropouts was found with regard to sociodemographic variables , except that compliant patients were significantly older . Also , no differences in psychopathology were seen at the beginning of treatment , but compliant patients had a longer duration of illness . Compliant patients had higher doses of neuroleptics in the initial stabilization phase and correspondingly showed more extrapyramidal signs . Physicians rated compliant patients from the beginning as more cooperative . These patients also showed significantly higher scores in positive treatment expectations . In a stepwise regression analysis , positive illness concepts , the global assessment of functioning ( GAF ) , and the physicians ' view of patients ' cooperation predicted 19 percent of the variance . We concluded that the prediction of dropouts is insufficient and remains largely an unsolved problem . Future research should focus more on context factors in the search for clinical ly meaningful explanations of patient dropout from treatment RATIONALE Most first-episode schizophrenia patients will stop their medication after their acute symptoms improve . Underst and ing the salient motivations and attitudes that drive adherence -- as well as nonadherence -- is an important part of developing strategies to prevent or delay nonadherence during the early phases of the illness . METHODS Self-reported reasons for adherence and nonadherence among first-episode and multi-episode patients with schizophrenia were obtained from cross-sectional adherence interviews from two prospect i ve adherence studies : one composed of a first-episode sample ( n=33 ) and the other with recently relapsing multi-episode patients ( n=16 ) . Both groups received the Rating of Medication Influences ( ROMI ) Scale at approximately 16 to 20 weeks after an acute psychotic episode . The specific ROMI items were ranked in order of percentage ( % ) strong , and were compared both within each patient group for rank order of importance , and also compared between groups to determine the differences in specific adherence and nonadherence influences . RESULTS The doctor-patient relationship was more likely to be endorsed as a strong adherence influence in the first-episode sample ( 74 % ) than in the multi-episode sample ( 13 % , X²=18.07 , p<.01 ) . Change in physical appearance attributed to medication was a more commonly endorsed nonadherence influence for the multi-episode sample ( 25 % ) relative to the first-episode sample ( 0 % , X²=9.2 , p<.01 ) . CONCLUSIONS The doctor-patient relationship st and s out as being the major reason for ongoing adherence for first-episode schizophrenia patients . Our post hoc interpretation is that lack of prior experience with medication and treatment elevates the importance of the relationship with the treating clinician for first-episode patients Abstract Objective : To identify reasons for discontinuation and continuation of antipsychotic medications in the treatment of schizophrenia from the patients ’ and their clinicians ’ perspectives . Research design and methods : Two measures were previously developed to assess the Reasons for Antipsychotic Discontinuation/Continuation ( RAD ) , one from the patient 's perspective and another from the clinician 's perspective . These measures were administered to acutely ill schizophrenia patients enrolled in a 12-week study of antipsychotic medications ( N = 596 ) and to their clinicians . The RAD was assessed at baseline and at endpoint . Reasons were rated on a 5-point scale from ‘ primary reason ’ to ‘ not a reason . ’ The single most important reason was also identified . The ‘ single most important reason ’ and the ‘ primary reasons ’ for discontinuing the drug used prior to enrollment , and for discontinuing or continuing the study drug were identified . Levels of concordance between patients ’ and clinicians ’ reasons were assessed . Clinical trial registration : The data source for this study is a clinical trial registered at www . clinical trials.gov ( NCT00337662 ) . Main outcome measures : Reasons for Antipsychotic Discontinuation/Continuation ( RAD ) . Results : Patients and clinicians identified several reasons for medication discontinuation and continuation ( 2.3 to 6.3 reasons , on average ) . The top ‘ single most important ’ reason for discontinuing the drug used prior to enrollment and for discontinuing the study drug was ‘ positive symptoms not sufficiently improved or made worse , ’ followed by ‘ medication-related adverse events . ’ The most frequent ‘ single most important ’ reason for medication continuation was ‘ improved positive symptoms , ’ followed by ‘ patient 's perception of improvement , ’ and ‘ functional improvement . ’ A high level of concordance was observed between patients ’ and clinicians ’ ratings . Conclusions : Medication efficacy appears to be the core driver of medication discontinuation and continuation , especially with regard to positive symptoms . There was a high level of concordance between patients ’ and clinicians ’ perspectives . Limitations include the study requirement that patients be at least moderately ill and experiencing acute psychotic exacerbation , a potential selection bias in the readiness to respond to measures , and small sample sizes for some analyses . Further research is needed to replicate findings in patients who are not acutely ill ABSTRACT Objectives : During a schizophrenia treatment episode , persistence with the initial antipsychotic may indicate optimal pharmacotherapy and be a precursor to longer-term effectiveness and other positive outcomes . The objective of this study was to examine the ability of selected variables to predict antipsychotic persistence among patients receiving olanzapine or risperidone as initial treatment . Research design and methods : Data for this analysis , which was not defined in the original study protocol , came from a naturalistic , r and omized , open-label trial comparing costs and effectiveness of first-line antipsychotic treatment options in schizophrenia . Predictor variables were as follows : ( 1 ) patients ’ initial antipsychotic ( olanzapine [ n = 222 ] or risperidone [ n = 218 ] ) ; ( 2 ) current ( within 30 days ) comorbid diagnosis of substance abuse ; and ( 3 ) nine self-report items from the Rating of Medication Influence ( ROMI ) scale , including an item assessing patients ’ perceptions of the role of their therapeutic alliance in their adherence . Main outcome measures : For the primary analysis , a stepwise logistic regression was used in predicting antipsychotic persistence of at least 180 days . Variables found to be significantly predictive were included in a second analysis that assessed persistence at additional thresholds ( > 90 days , > 270 days , and completion of the 1‑year study ) . Results : Four variables predicted longer antipsychotic persistence ; olanzapine as initial antipsychotic ( p = 0.004 ) , absence of comorbid substance abuse ( p = 0.025 ) , and two of the ROMI items representing patients ’ subjective response to treatment – positive relationship with clinical staff ( p = 0.048 ) and fulfillment of life goals ( p = 0.050 ) . Conclusions : Within a r and omized trial design , this study corroborated the influence of several factors on antipsychotic persistence in schizophrenia . Results support the importance of the initial antipsychotic treatment option , presence of a comorbid substance abuse diagnosis , and the role of patients ’ subjective responses . Additional research is needed to further explore these and other factors as predictors of antipsychotic persistence , and of subsequent treatment outcomes OBJECTIVE Time to all-cause treatment discontinuation is considered a composite proxy measure of treatment efficacy , safety , and tolerability . Longer time to discontinuation of antipsychotic medication for any cause has been shown to be associated with greater symptom improvements in the treatment of schizophrenia . This study examines whether longer time to all-cause medication discontinuation is also linked to better functional outcomes . METHOD Using pooled data from 4 r and omized , double-blind antipsychotic trials of 24- to 28-weeks ' duration , this study examined the association between time to all-cause treatment discontinuation and functional outcomes , as assessed by a disease-specific , clinician-rated measure ( Quality of Life Scale [ QLS ] ) and a generic , patient-reported measure ( Medical Outcomes Study Short Form 36 [ SF-36 ] ) . Patients in these trials had a DSM-IV diagnosis of schizophrenia , schizophreniform disorder , or schizoaffective disorder . This post hoc analysis used Pearson partial correlations to assess relationships between time to treatment discontinuation and changes in functional scores , adjusting for baseline scores . Repeated measures analyses were also conducted to compare post-baseline functional outcome change over time between completers and noncompleters . RESULTS Longer time to all-cause treatment discontinuation was found to be significantly associated with greater improvements in all assessed functional domains ( p < .05 ) . Patients who completed their respective trials ( 46.8 % , 761/1627 ) experienced significantly greater improvement in functional outcome measures ( in 4 QLS domains and SF-36 mental health component summary score ; all , p < .001 ) compared to patients who discontinued for any cause . In addition , greater symptom improvement was significantly associated with greater functional improvements in assessed domains . CONCLUSIONS Findings from this post hoc analysis illustrate the importance of longer treatment duration with antipsychotics for improving functional outcomes in the treatment of patients with schizophrenia Output:	Reasons for both adherence and non-adherence were largely similar ; medication efficacy , compatibility with personal medication or religious beliefs , side-effects and the influence of relationships with other people .
MS2632	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background —There is no disease specific , reliable , and valid clinical measure of Achilles tendinopathy . Objective —To develop and test a question naire based instrument that would serve as an index of severity of Achilles tendinopathy . Methods —Item generation , item reduction , item scaling , and pretesting were used to develop a question naire to assess the severity of Achilles tendinopathy . The final version consisted of eight questions that measured the domains of pain , function in daily living , and sporting activity . Results range from 0 to 100 , where 100 represents the perfect score . Its validity and reliability were then tested in a population of non-surgical patients with Achilles tendinopathy ( n = 45 ) , presurgical patients with Achilles tendinopathy ( n = 14 ) , and two normal control population s ( total n = 87 ) . Results —The VISA-A question naire had good test-retest ( r = 0.93 ) , intrarater ( three tests , r = 0.90 ) , and interrater ( r = 0.90 ) reliability as well as good stability when compared one week apart ( r = 0.81 ) . The mean ( 95 % confidence interval ) VISA-A score in the non-surgical patients was 64 ( 59–69 ) , in presurgical patients 44 ( 28–60 ) , and in control subjects it exceeded 96 ( 94–99 ) . Thus the VISA-A score was higher in non-surgical than presurgical patients ( p = 0.02 ) and higher in control subjects than in both patient population s ( p<0.001 ) . Conclusions —The VISA-A question naire is reliable and displayed construct validity when means were compared in patients with a range of severity of Achilles tendinopathy and control subjects . The continuous numerical result of the VISA-A question naire has the potential to provide utility in both the clinical setting and research . The test is not design ed to be diagnostic . Further studies are needed to determine whether the VISA-A score predicts prognosis Background The common regime of eccentric exercise in use for Achilles tendinopathy is somewhat arduous and compliance issues can arise . This is the first study to investigate the effectiveness of a regime of fewer exercise sessions combined with photobiomodulation for the treatment of Achilles tendinopathy . Methods A double blind r and omized controlled trial and intention-to-treat analysis were performed . Eighty participants , 18–65 years with Achilles tendinopathy and symptoms for longer than 3 months , were included in the trial . Participants r and omized into one of four groups ; 1 ( Placebo + Ex Regime 1 ) or 2 ( Laser + Ex Regime 1 ) or 3 ( Placebo + Ex Regime 2 ) or 4 ( Laser + Ex Regime 2 ) . The primary outcome measure was the Victorian Institute of Sports Assessment -Achilles ( VISA-A ) question naire . Outcomes were collected at baseline , week 4 and week 12 . Results Sixteen participants were lost to follow-up at 12 weeks , 4 of which due to adverse reactions . As per intention to treat , missing data were imputed , 80 participants were included in the final analysis . For VISA-A at 12 weeks , group 4 achieved significant gains over the other 3 groups : group 1 ( 18.5 [ 9.1 , 27.9 ] ) , group 2 ( 10.4 [ 1.5 , 19.2 ] ) , group 3 ( 11.3 [ 3.0 , 19.6 ] ) . There was a moderate effect size in favour of exercise twice per week ( 7.2 [ −1.8 , 16.2 ] , ES .7 ) . Conclusions Twice-daily exercise sessions are not necessary as equivalent results can be obtained with two exercise sessions per week . The addition of photobiomodulation as adjunct to exercise can bring added benefit Background Synthesis of multiple r and omized controlled trials ( RCTs ) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions . Filtering of search es is time consuming , and no single method fulfills the principal requirements of speed with accuracy . Automation of systematic review s is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making . We developed Rayyan ( http://rayyan.qcri.org ) , a free web and mobile app , that helps expedite the initial screening of abstract s and titles using a process of semi-automation while incorporating a high level of usability . For the beta testing phase , we used two published Cochrane review s in which included studies had been selected manually . Their search es , with 1030 records and 273 records , were uploaded to Rayyan . Different features of Rayyan were tested using these two review s. We also conducted a survey of Rayyan ’s users and collected feedback through a built-in feature . Results Pilot testing of Rayyan focused on usability , accuracy against manual methods , and the added value of the prediction feature . The “ taster ” review ( 273 records ) allowed a quick overview of Rayyan for early comments on usability . The second review ( 1030 records ) required several iterations to identify the previously identified 11 trials . The “ suggestions ” and “ hints , ” based on the “ prediction model , ” appeared as testing progressed beyond five included studies . Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements . The survey respondents reported 40 % average time savings when using Rayyan compared to others tools , with 34 % of the respondents reporting more than 50 % time savings . In addition , around 75 % of the respondents mentioned that screening and labeling studies as well as collaborating on review s to be the two most important features of Rayyan . As of November 2016 , Rayyan users exceed 2000 from over 60 countries conducting hundreds of review s totaling more than 1.6 M citations . Feedback from users , obtained mostly through the app web site and a recent survey , has highlighted the ease in exploration of search es , the time saved , and simplicity in sharing and comparing include-exclude decisions . The strongest features of the app , identified and reported in user feedback , were its ability to help in screening and collaboration as well as the time savings it affords to users . Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of review ers Background : Low level laser therapy ( LLLT ) has gained increasing popularity in the management of tendinopathy and arthritis . Results from in vitro and in vivo studies have suggested that inflammatory modulation is one of several possible biological mechanisms of LLLT action . Objective : To investigate in situ if LLLT has an anti-inflammatory effect on activated tendinitis of the human Achilles tendon . Subjects : Seven patients with bilateral Achilles tendinitis ( 14 tendons ) who had aggravated symptoms produced by pain inducing activity immediately before the study . Method : Infrared ( 904 nm wavelength ) LLLT ( 5.4 J per point , power density 20 mW/cm2 ) and placebo LLLT ( 0 J ) were administered to both Achilles tendons in r and om blinded order . Results : Ultrasonography Doppler measurements at baseline showed minor inflammation through increased intratendinous blood flow in all 14 tendons and measurable resistive index in eight tendons of 0.91 ( 95 % confidence interval 0.87 to 0.95 ) . Prostagl and in E2 concentrations were significantly reduced 75 , 90 , and 105 minutes after active LLLT compared with concentrations before treatment ( p = 0.026 ) and after placebo LLLT ( p = 0.009 ) . Pressure pain threshold had increased significantly ( p = 0.012 ) after active LLLT compared with placebo LLLT : the mean difference in the change between the groups was 0.40 kg/cm2 ( 95 % confidence interval 0.10 to 0.70 ) . Conclusion : LLLT at a dose of 5.4 J per point can reduce inflammation and pain in activated Achilles tendinitis . LLLT may therefore have potential in the management of diseases with an inflammatory component A linear analogue for rating pain with 10 , 15 and 20 cm lines is significantly less variable than a 5 cm line ( mean error of 15 cm line is 0 - 19 % , 95 % confidence limits for the group + /- 2 % and an inood correlation between repeated ratins of a recalled pain distant in time . The variance of the rating is significantly less than the repeated rating of a r and om mark . The linear analogue rating of a constant pain stimulus is reproducible and changes in rating are likely to be real changes of opinion . Pethidine 150 mg intramuscularly had no significant effect , tested 30 minutes after the administration , on the accuracy or reproducibility of the analogue rating . A linear analogue seems a suitable method of recording the patient 's opion of a severe pain such as that of labour Background Eccentric exercises ( EEs ) are recommended for the treatment of Achilles tendinopathy , but the clinical effect from EE has a slow onset . Hypothesis The addition of low-level laser therapy ( LLLT ) to EE may cause more rapid clinical improvement . Study Design R and omized controlled trial ; Level of evidence , 1 . Methods A total of 52 recreational athletes with chronic Achilles tendinopathy symptoms were r and omized to groups receiving either EE + LLLT or EE + placebo LLLT over 8 weeks in a blinded manner . Low-level laser therapy ( Λ = 820 nm ) was administered in 12 sessions by irradiating 6 points along the Achilles tendon with a power density of 60 mW/cm2 and a total dose of 5.4 J per session . Results The results of the intention-to-treat analysis for the primary outcome , pain intensity during physical activity on the 100-mm visual analog scale , were significantly lower in the LLLT group than in the placebo LLLT group , with 53.6 mm versus 71.5 mm ( P = .0003 ) at 4 weeks , 37.3 mm versus 62.8 mm ( P = .0002 ) at 8 weeks , and 33.0 mm versus 53.0 mm ( P = .007 ) at 12 weeks after r and omization . Secondary outcomes of morning stiffness , active dorsiflexion , palpation tenderness , and crepitation showed the same pattern in favor of the LLLT group . Conclusion Low-level laser therapy , with the parameters used in this study , accelerates clinical recovery from chronic Achilles tendinopathy when added to an EE regimen . For the LLLT group , the results at 4 weeks were similar to the placebo LLLT group results after 12 weeks OBJECTIVE To test the feasibility of a r and omized controlled trial to assess the clinical effectiveness of low-level laser therapy ( LLLT ) when used in addition to eccentric exercise in the management of Achilles tendinopathy . BACKGROUND DATA LLLT has emerged as a possible treatment modality for tendon injuries . Over the past 20 years only three human studies have investigated LLLT for Achilles tendinopathy . MATERIAL S AND METHODS Twenty patients were r and omized into an active laser or placebo group ; all patients , therapists , and investigators were blinded to allocation . All patients were given a 12-week eccentric exercise program and irradiated three times per week for 4 wk with either an active or placebo laser at st and ardized points over the affected tendons . Irradiation parameters in the active treatment group were : 810 nm , 100 mW , applied to six points on the tendon for 30 s , for a total dose of 3 J per point and 18 J per session . Outcome measures were the VISA-A question naire , pain , and isokinetic strength . Patients were measured before treatment and at 4 and 12 wk . Analysis of covariance was used to analyze data , using the effects of baseline measurements as a covariate . RESULTS Within groups , there were significant improvements ( p < 0.05 ) at 4 and 12 wk for all outcome measures , except eccentric strength for the placebo group at 4 wk ( p = 0.11 ) . Based on the results of the current study , recruitment of 20 subjects per group would be required to perform an adequately powered study based on minimally important clinical differences in VISA-A scale . CONCLUSION This study has demonstrated the feasibility of undertaking a r and omized controlled trial of LLLT for Achilles tendinopathy . Conclusions regarding effectiveness can not be made due to the low statistical power of this pilot study & NA ; The purpose of this study was to determine the levels of change on st and ard pain scales that represent clinical ly important differences to patients . Data from analgesic studies are often difficult to interpret because the clinical importance of the results is not obvious . Differences between groups , as summarized by a change in mean values over time , can be difficult to apply to clinical care . Baseline scores vary widely and group mean differences could reflect large changes in a few patients , small changes in many patients , or any combination of these outcomes . Determination of the proportion of patients who have a clinical ly important improvement in their pain would provide a more interpretable result with direct clinical implication s. However , determining a clinical ly important outcome requires information about the degree of change over time that is clinical ly important . Data from the titration phase of a multiple cross‐over r and omized clinical trial of oral transmucosal fentanyl citrate ( OTFC ) for the treatment of cancer‐related breakthrough pain were re‐analyzed to examine the differences in pain scores between treatment episodes that did and did not yield adequate pain relief . The scales evaluated were absolute pain intensity difference ( PID , 0–10 scale ) , percentage pain intensity difference ( PID% , 0–100 % scale ) , pain relief ( PR , 0 ( none ) , 1 ( slight ) , 2 Output:	The certainty of evidence was low to very low , and the results are insufficient to support the routine use laser therapy for Achilles tendinopathy
MS2633	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND In chronic diseases adherence is a problem . Little is known about adherence to antidepressants after the acute phase in recurrent depression . This study evaluates adherence to antidepressants in the continuation and maintenance phase in remitted recurrently depressed patients . METHODS We prospect ively assessed adherence to continuation and maintenance antidepressant use , the longest phase in antidepressant treatment , over 2 years and the association of adherence with future recurrence in 131 recurrently depressed patients remitted on antidepressants . LIMITATIONS Self reported non-adherence . RESULTS Non-adherence ranged from 39.7 % to 52.7 % ; 20.9 % were always non-adherent , 48.4 % were intermittently non-adherent and 30.8 % were always adherent . Adherence rates did not significantly differ between intermittent and continuous antidepressant users ( 37.2 % vs. 25 % ) . Non-adherence predicted time to recurrence . CONCLUSION Non-adherence to continuation and maintenance antidepressant treatment in recurrent depression is frequent , like in other chronic diseases , and a potential risk of recurrence . Doctors continuously have to be aware of this problem and should keep on discussing it with their patients . Finally , as many patients do n't seem to be able or willing to take AD as prescribed , alternatives to prevent relapse deserve more attention AIMS To assess the advantages and disadvantages of four methods for study ing compliance with antidepressants : self-report scores , tablet counts , a microprocessor ( MEMS ) container system and the assay of nordothiepin and dothiepin concentrations in plasma . METHODS The techniques were used in 88 patients commencing tricyclic antidepressants in the setting of UK general practice . RESULTS The MEMS system proved to be the most informative technique allowing identification of the precise time of container opening , the demonstration of ' drug holidays ' and early cessation of therapy . Self-report scores ( Morisky ) proved a useful screening technique with a sensitivity of 72.2 % and specificity of 74.1 % for > or = 80 % compliance . Although tablet counts were possible in 84 patients ( 95 . 5 % ) they were unreliable in 19 ( 21.6 % ) . Blood concentration assays proved the least acceptable method to patients and were possible in only 53 ( 60.2 % ) . A ratio of nordothiepin : dothiepin > or = 1.1 cl aim ed , by others , to identify noncompliance was only reliable when concentrations were low . CONCLUSIONS Both the MEMS system and self-report scores proved useful methods for identifying noncompliant patients in the setting of UK general practice . Although compliance was higher than reported in previous studies with 70 patients ( 79.5 % ) completing 6 weeks treatment , general practitioners tended to prescribe subtherapeutic doses BACKGROUND This research study evaluates the effectiveness of a multifaceted intervention program to improve the management of depression in primary care . METHODS One hundred fifty-three primary care patients with current depression were entered into a r and omized controlled trial . Intervention patients received a structured depression treatment program in the primary care setting that included both behavioral treatment to increase use of adaptive coping strategies and counseling to improve medication adherence . Control patients received " usual " care by their primary care physicians . Outcome measures included adherence to antidepressant medication , satisfaction with care of depression and with antidepressant treatment , and reduction of depressive symptoms over time . RESULTS At 4-month follow-up , significantly more intervention patients with major and minor depression than usual care patients adhered to antidepressant medication and rated the quality of care they received for depression as good to excellent . Intervention patients with major depression demonstrated a significantly greater decrease in depression severity over time compared with usual care patients on all 4 outcome analyses . Intervention patients with minor depression were found to have a significant decrease over time in depression severity on only 1 of 4 study outcome analyses compared with usual care patients . CONCLUSION A multifaceted primary care intervention improved adherence to antidepressant regimens and satisfaction with care in patients with major and minor depression . The intervention consistently result ed in more favorable depression outcomes among patients with major depression , while outcome effects were ambiguous among patients with minor depression Measurement of adherence is complex and many methods , both direct and indirect are used ; there is no universal gold st and ard . In this article , we share our experiences in a r and omised controlled study , the Hypertension Adherence Program in Pharmacy trial , evaluating a community pharmacy-based intervention for improving adherence to antihypertensive medication . Several objective and subjective measures of adherence ( Morisky score , TABS score , MedsIndex , Medicines Possession Ratio ) were used , but produced varying results , limiting confidence in the conclusions that could be drawn . Despite using a specifically design ed data mining software program to identify potentially nonadherent patients from dispensing records , many participants were found to be adherent by the self reported Morisky scale . A lesson to be learned when targeting people for interventions to improve adherence is that information from dispensing records should be supplemented by other methods in order to identify patients most in need of assistance PURPOSE The impact of pharmacist interventions on the care and outcomes of patients with depression in a primary care setting was evaluated . METHODS Patients diagnosed with a new episode of depression and started on anti-depressant medications were r and omized to enhanced care ( EC ) or usual care ( UC ) for one year . EC consisted of a pharmacist collaborating with primary care providers to facilitate patient education , the initiation and adjustment of antidepressant dosages , the monitoring of patient adherence to the regimen , the management of adverse reactions , and the prevention of relapse . The patients in the UC group served as controls . Outcomes were measured by the Hopkins Symptom Checklist , Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , criteria for major depression , health-related quality of life , medication adherence , patient satisfaction , and use of depression-related health care services . An intent-to-treat analysis was used . RESULTS Seventy-four patients were r and omized to EC or UC . At baseline , the EC group included more patients diagnosed with major depression than did the UC group ( p = 0.04 ) . All analyses were adjusted for this difference . In both groups , mean scores significantly improved from baseline for symptoms of depression and quality of life at three months and were maintained for one year . There were no statistically significant differences between treatment groups in depression symptoms , quality of life , medication adherence , provider visits , or patient satisfaction . CONCLUSION Frequent telephone contacts and interventions by pharmacists and UC in a primary care setting result ed in similar rates of adherence to antidepressant regimens and improvements in the outcomes of depression at one year BACKGROUND A new formulation of enteric-coated fluoxetine given once weekly could be a useful option for the long-term treatment of depression , but compliance to once-weekly fluoxetine treatment has not been assessed . METHOD Patients were adults from the United Kingdom who had responded to fluoxetine treatment for a current episode of depression ( DSM-IV criteria ) . In the baseline assessment phase , all patients ( N = 117 ) were continued on 20 mg of open-label fluoxetine once daily for 4 weeks . In the follow-up phase , patients ( N = 109 ) were r and omly assigned to once-weekly or once-daily fluoxetine for 3 months . Patient compliance was monitored by electronic devices during both phases of the study . RESULTS Compliance to once-weekly fluoxetine treatment was higher than compliance to once-daily fluoxetine ( 85.9 % vs. 79.4 % , respectively ) . CONCLUSION Once-weekly fluoxetine treatment allows for new flexibility for both the clinician and the patient , and this study alleviates the concern that patients will forget weekly doses The goals of this study were to examine how physician communication style impacts client beliefs and medication taking behavior during treatment for depression . The study uses a communication framework and prospect i ve design to examine physician communication and client beliefs as treatment is initiated and again 2 months later . Two telephone interviews were conducted with 100 clients enrolled from 23 community pharmacies . Clients report that physician communication styles vary . In follow-up , 25 % of the clients were not satisfied with their medication and 82 % reported missing doses or stopping treatment earlier than recommended . Path analysis showed that physician initial communication style positively influences client knowledge and initial beliefs about the medication . Clients with more positive beliefs about the treatment are more likely to see the physician in follow-up and are more satisfied with treatment after attempting medication use . Physician follow-up communication style and client satisfaction are both predictive of better medication adherence Abstract Objectives : To evaluate two different methods of improving adherence to antidepressant drugs . Design : Factorial r and omised controlled single blind trial of treatment leaflet , drug counselling , both , or treatment as usual . Setting : Primary care in Wessex Participants : 250 patients starting treatment with tricyclic antidepressants . Main outcome measures : Adherence to drug treatment ( by confidential self report and electronic monitor ) ; depressive symptoms and health status . Results : 66 ( 63 % ) patients continued with drugs to 12 weeks in the counselled group compared with 42 ( 39 % ) of those who did not receiving counselling ( odds ratio 2.7 , 95 % confidence interval 1.6 to 4.8 ; number needed to treat=4 ) Treatment leaflets had no significant effect on adherence . No differences in depressive symptoms were found between treatment groups overall , although a significant improvement was found in patients with major depressive disorder receiving drug doses of at least 75 mg ( depression score 4 ( SD 3.7 ) counselling v 5.9 ( SD 5.0 ) no counselling , P=0.038 ) . Conclusions : Counselling about drug treatment significantly improved adherence , but clinical benefit was seen only in patients with major depressive disorder receiving doses ≥75 mg . Further research is required to evaluate the effect of this approach in combination with appropriate targeting of treatment and advice about dosage . Key messages Non-adherence is a serious problem in the treatment of depression by general practitioners In this study a brief psychosocial intervention delivered by a nurse greatly improved adherence Clinical benefit was apparent only in patients with major depressive episodes on higher doses of drugs Counselling should be targeted at patients with symptoms of at least moderate severity and combined with therapeutic drug Medication non-adherence is a major obstacle in the treatment of affective disorders . The primary objective of this study was to evaluate two different interventions to improve adherence to antidepressant drugs . Secondary objectives included response to treatment , relation between adherence and response , patient satisfaction and tolerability . A r and omized controlled design was used to assess the effect of a patient educational compliance enhancing programme ( CP ) and therapeutic drug monitoring in 1031 major depressed patients treated with sertraline for 24 weeks and managed by their general practitioner . Adherence was measured by question ing , measurable serum levels of sertraline and desmethylsertraline , appointments kept and a composite index including all three methods . Treatment adherence was found in 37–70 % of patients , depending on the method used . Neither of the interventions result ed in a significant increase in adherence rate . However , significantly more patients in the CP group had responded at week 24 compared to patients in the control group . Overall , significantly more adherent patients responded to treatment compared to non-adherent patients , regardless of method used to determine adherence . This large study demonstrates that treatment response increases when using an educational compliance programme and that a strong relationship between treatment adherence and response exists The effects on adherence and depressive symptoms of a community pharmacy-based coaching program , including a take-home videotape , were evaluated in a r and omized controlled trial in the Netherl and s. A total of 147 depressed primary care patients who had a new antidepressant prescription were included in the study . Adherence was measured with an electronic pill container and was also derived from pharmacy medication records ; the latter method was associated with an overestimation of adherence of only 5 percent . Intention-to-treat analyses showed no intervention effect on adherence ( 73 percent compared with 76 percent ) , whereas analyses of patients who received the intervention ( per protocol ) showed improved adherence ( 73 percent compared with 90 percent ) . Neither analysis showed effects on depressive symptoms Background : Medication adherence is suboptimal , and clinicians and research ers struggle with identifying nonadherent patients . Various measures of medication adherence exist , but there is controversy regarding which measures provide acceptable data and how nonadherence should be defined . Objective : To assess agreement among patient self-report , pharmacy refill , and electronic adherence measures and compare the sensitivity and specificity of different cut-points for defining nonadherence . Methods : Data were analyzed from 2 similarly design ed r and omized controlled trials that assessed a pharmacist 's intervention to improve medication adherence among patients with hypertension or heart failure . For each participant , adherence was measured by patient self-report , prescription refill records , and electronic lids on medication containers . Agreement among measures was assessed using Spearman 's correlation coefficient rho . Correlation coefficients were compared by patient characteristics using Fisher 's Z transformation , The sensitivity and specificity of different cut-points for defining nonadherence were calculated . Results : Median adherence was 84 % for self-report , 86 % for electronic , and 91 % for prescription refill adherence measurement . Refill and electronic adherence demonstrated the best agreement among measures ( rho = 0.48 ) . Age , depression , and other comorbid conditions Output:	Self‐report measures were the most frequently used , followed by electronic lid devices and pharmacy records . St and ardized self‐report measures such as Morisky , Green , and Levine Self‐Reported Medication Taking Scale ( MGLS ) and Antidepressant Adherence Scale ( AAS ) demonstrated acceptable reliability and validity , while medication cl aims data showed good reliability as a long‐term measure . Conclusions : Although the psychometric properties of various measures have been evaluated across the three phases of adherence , a st and out measure with strong reliability and validity was not apparent . No single measure demonstrated reliability and validity throughout the adherence process .
MS2634	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The efficacy of low-dose heparin in preventing fatal postoperative pulmonary embolism has been investigated in a multicentre prospect i ve r and omised trial . 4121 patients over the age of forty years undergoing a variety of elective major surgical procedures were included in the trial ; 2076 of these were in the control group and 2045 patients received heparin . The two groups were well matched for age , sex , weight , blood-group , and other factors which could predispose to the development of venous thromboembolism . 180 ( 4 - 4 % ) patients died during the postoperative period , 100 in the control and 80 in the heparin group : 72 % of deaths in the control and 66 % in the heparin group had necropsy examination . 16 patients in the control group and 2 in the heparin group were found at necropsy to have died due to acute massive pulmonary embolism ( P smaller than 0 - 005 ) . In addition , emboli found at necropsy in 6 patients in the control group and 3 in the heparin group were considered either contributory to death or an incidental finding since death in these patients was attributed to other causes . Taking all pulmonary emboli together , the findings were again significant ( P smaller than 0 - 005 ) . Of 1292 patients in whom the 125-I-fibrinogen test was performed to detect deep-vein thrombosis ( D.V.T. ) 667 were in the control group and 625 in the heparin group . The frequency of isotopic D.V.T. was reduced from 24 - 6 % in the control group 7 - 7 % in the heparin group ( P smaller 0 - 005 ) . In 30 patients D.V.T. was detected at necropsy ; 24 in the control and 6 in the heparin group ( P smaller 0 - 005 ) . 32 patients in the control group and 11 in the heparin group developed clinical ly diagnosed D.V.T. which was confirmed by venography ( P smaller than 0 - 005 ) . In addition , 24 patients in the control and 8 in the heparin group were treated for clinical ly suspected pulmonary emoblism . The difference in the number of patients requiring treatment for D.V.T. and /or pulmonary embolism in the two groups was again significant ( P smaller than 0 - 005 ) . 9 patients were found at necropsy to have died from haemorrhage ; 5 were in the control and 4 in the heparin group . A careful objective analysis of operative and postoperative bleeding in 1475 patients showed no statistically significant difference in the blood-transfusion requirements or in the fall in the postoperative haemoglobin level either in the individual operative groups or in the group as a whole . However , the difference in the number of patients who developed wound haematoma in the heparin and control groups was significant ( P smaller 0 - 01 ) . The results of the trial indicate that this form of prophylaxis can now be recommended for use on a large scale in " high-risk " patients undergoing major surgery BACKGROUND The risk of deep-vein thrombosis ( DVT ) and pulmonary embolism after total hip replacement ( THR ) surgery may persist after hospital discharge , but the extent of the risk is not known . We carried out a single-centre , prospect i ve , r and omised , double-blind trial with the aims of quantifying this risk and assessing the efficacy of continued prophylactic treatment . METHODS At hospital discharge 13 - 15 days after surgery , we recruited 179 consecutive THR patients who had no DVT visible on bilateral ascending venography of the legs . The patients were r and omly assigned subcutaneous enoxaparin ( 40 mg , once daily ; n = 90 ) or placebo ( n = 89 ) for 21 ( 19 - 23 ) days . The primary endpoint was the occurrence of DVT or pulmonary embolism . Venography was repeated at the end of 21 days ' treatment or earlier if necessary . FINDINGS There were no deaths and no symptomatic pulmonary embolisms during the study or follow-up periods . Of 173 patients with evaluable venograms , intention-to-treat analysis of efficacy showed that the rate of DVT at day 21 after discharge was significantly lower in the enoxaparin group than in the placebo group ( 6 [ 7.1 % ] vs 17 [ 19.3 % ] , p = 0.018 ) . Distal DVT was detected in one ( 1.2 % ) patient in the enoxaparin group and in ten ( 11.4 % ) patients in the placebo group ( p = 0.006 ) . Proximal DVT was observed in five ( 5.9 % ) patients in the enoxaparin group and in seven ( 7.9 % ) patients in the placebo group ( p = 0.592 ) . A per protocol analysis of efficacy in 155 patients confirmed these findings . Safety was good ; three minor bleeding episodes occurred in the enoxaparin group and one in the placebo group , but none of these episodes necessitated withdrawal from the study . INTERPRETATION In patients who have undergone THR surgery , are without venogram-proven DVT at hospital discharge , and do not receive antithrombotic prophylaxis after discharge , the risk of late-occurring DVT remains high at least until day 35 after surgery . Continued prophylaxis with enoxaparin is effective and safe in reducing this risk In a r and omized , prospect i ve trial of 100 patients , we have studied the safety and efficacy of warfarin sodium in comparison with that of dextran 40 in the prevention of venous thrombosis in patients at high risk for deep vein thrombosis after elective total hip or knee replacement . Warfarin was given in a new two-step regimen design ed to avoid bleeding complications while still preventing venous thrombosis . A low dose of warfarin was started ten to 14 days preoperatively , and the prothrombin time was regulated to between 1.5 and 3 seconds longer than control at the time of surgery ; immediately after surgery , the dose was increased to prolong the prothrombin time to 1.5 times control . The overall incidence of venous thrombosis as documented by venography was less in the 53 patients treated with warfarin than in the 37 treated with dextran ( 21 % v 51 % ) , as was the incidence of thrombi in the femoral or popliteal veins ( 2 % v 16 % ) . Objective measures of blood loss showed no difference between patients treated with warfarin or dextran , and excessive postoperative bleeding was infrequent and similar in both treatment groups . This study demonstrates that two-step warfarin therapy provides highly effective prophylaxis of postoperative venous thrombosis after elective hip or knee prosthetic surgery without excessive risk of perioperative bleeding The effect of low-dose heparin prophylaxis on venous thrombosis and bleeding after major elective surgery was studied in a prospect i ve controlled study of 820 patients . The total incidence of venous thrombosis detected with leg-scanning using fibrinogen labeled with radioactive iodine ( 125I ) was reduced from 16.0 % in the control group to 4.2 % in treated patients . More important , the incidence of popliteal or femoral vein thrombosis was reduced from 2.9 % to 1.0 % . Prophylaxis result ed in a slight increase in bleeding-minor wound hematoma , mean volume of blood transfused , and a post-operative hematocrit fall in treated patients . However , increased bleeding was clinical ly minor , and prophylaxis was well tolerated Discontinuation of thromboprophylaxis a few days after surgery may unmask delayed hypercoagulability and contribute to late formation of deep venous thrombosis ( DVT ) . To investigate whether thromboprophylaxis should be prolonged beyond the hospital stay , a prospect i ve , double-blind r and omised study was conducted in 308 patients . All patients received initial thromboprophylaxis with dalteparin , dextran and grade d elastic stockings . On day 7 , patients were r and omised to receive dalteparin ( Fragmin ) 5000 i.u . once daily , or placebo , for 4 weeks . All patients were subjected to bilateral venography , perfusion ventilation scintigraphy and chest X-ray on days 7 and 35 . Patients with venographically verified proximal DVT on day 7 were withdrawn from the r and omised study to receive anticoagulant treatment . The overall prevalence of DVT on day 7 was 15.9 % . On day 35 , the prevalence of DVT was 31.7 % in placebo-treated patients compared with 19.3 % in dalteparin-treated patients ( p = 0.034 ) . The incidence of DVT from day 7 to day 35 was 25.8 % in the placebo-treated group versus 11.8 % in the dalteparin-treated group ( p = 0.017 ) . The incidence of symptomatic pulmonary embolism ( PE ) from day 7 to day 35 was 2.8 % in the placebo-treated group compared with zero in the dalteparin-treated group . This included one patient who died from PE . No patients experienced serious complications related to the injections of dalteparin or placebo . This study shows that prolonged thromboprophylaxis with dalteparin . 5000 IU , once daily for 35 days significantly reduces the frequency of DVT and should be recommended for 5 weeks after hip replacement surgery OBJECTIVE To compare efficacy , safety , and feasibility of adjusted-dose oral anticoagulants ( OAC ) versus fixed-dose subcutaneous low molecular weight heparin ( LMWH ) for the prevention of deep venous thrombosis ( DVT ) in patients who have undergone elective hip or knee replacement . DESIGN Multicentre , single blind r and omised trial . OAC ( acenocoumarol , target International Normalised Ratio , 2.0 - 3.0 ) and LMWH ( nadroparine , 60 aXa IU/kg once daily ) were started preoperatively and continued for 10 days . All outcome measures were adjudicated by an independent committee unaware of treatment allocation . SUBJECTS 672 consecutive patients scheduled for elective hip or knee replacement surgery . All patients wore bilateral graduated compression stockings . MAIN OUTCOME MEASURES The endpoint for the assessment of efficacy was venography confirmed DVT or confirmed symptomatic pulmonary embolism . The endpoint for the assessment of safety was clinical ly important bleeding during study treatment or within 48 h of the end of treatment . RESULTS Among the 517 patients with interpretable venograms , 391 had a hip replacement and 126 had a knee implant . DVT was demonstrated in 50 ( 20 % ) of 257 patients allocated to OAC and 43 ( 17 % ) of 260 patients allocated to nadroparine ( p = 0.45 ) , for an absolute difference in DVT incidence of 2.9 % in favour of nadroparine ( 95 % CI , -3.7 - 9.5 ) . Clinical ly important bleeding occurred in eight ( 2.3 % ) of the 342 oral anticoagulant treated patients and in five ( 1.5 % ) of the 330 nadroparine treated patients ( p = 0.62 ) , for an absolute difference in favour of nadroparine of 0.8 % ( 95 % Cl , -1.3 - 2.9 ) . CONCLUSION Patients who undergo major orthopaedic operations have a high risk of venous thromboembolism . Once daily fixed-dose subcutaneous nadroparine is at least as efficacious and safe as daily adjusted OAC for prophylaxis against DVT after hip or knee implantation but is more simple to administer Abstract The efficacy of small doses of peri-operative subcutaneous heparin in preventing deep venous thrombosis has been studied in a controlled clinical trial involving 251 patients undergoing major operations . The results indicate that the regimen of sodium heparin used was safe . It reduced the frequency of postoperative deep venous thrombosis from 24 % in the control group to 0·8 % in the test group as detected by the 125 I-fibrinogen test . In addition it reduced the frequency of the dangerous extensive thrombi often responsible for pulmonary emboli from 7.4 % to In a prospect i ve study all positive phlebographies within the well-defined population of the city of Malmö , Sweden , during 1987 were studied in order to determine the incidence of deep venous thrombosis ( DVT ) . Epidemiological data were analysed for the detection of patient groups at increased risk of DVT . The incidence was found to be equal for both sexes , i.e. 1.6 per 1000 inhabitants a year . Risk factors were found to be in accordance with earlier studies . The median age for men was 66 years , compared to 72 years for women . At diagnosis of DVT , 19 % of subjects had a known malignancy and within 1 year 5 % ( 19 cases ) developed a new malignancy . Of the men , 29 % had postoperative or post-traumatic ( fracture ) DVT , compared to 46 % of the women . Fewer patients with DVT than expected ( 39 % ) belonged to blood group 0 ( 31 % ) ( P less than 0.005 ) . Pulmonary embolism Output:	Low-molecular-weight heparin initiated 12 hours before surgery or 12 to 24 hours postoperatively was not more effective than oral anticoagulants . Low-molecular-weight heparin initiated postoperatively in close proximity to surgery at half the usual dose was not associated with a clinical ly or statistically significant increase in major bleeding rates ( P = .16 ) . The timing of initiating low-molecular-weight heparin significantly influences antithrombotic effectiveness . The practice of delayed initiation of low-molecular-weight heparin prophylaxis results in suboptimal antithrombotic effectiveness without a substantive safety advantage
MS2635	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The present study aim ed to evaluate the efficacy of three-year subcutaneous SQ-st and ardized specific immunotherapy ( SCIT ) in house dust mite (HDM)-allergic children with asthma . Ninety children with allergic asthma to HDMs , with or without allergic rhinitis , were r and omly divided into two groups , the treatment group and the control group . The treatment group received SCIT combined with st and ardized glucocorticoid management and the control group received st and ardized glucocorticoid management alone for a period of three years . The mean daily dose of inhaled corticosteroids ( ICSs ) , a four-week diary recording the symptom scores of asthma , peak expiratory flow ( PEF ) measurements , skin prick test results and serum immunoglobulin E ( IgE ) levels were assessed prior to treatment and following one , two and three years of treatment . The median dose of ICS was reduced in the treatment group after two and three years of treatment compared with that of the control group . After three years of treatment , the discontinuation percentage of ICS in the treatment group was higher than that in the control group . The treatment group demonstrated significantly reduced daytime and night-time asthmatic symptom scores , increased PEF values and reduced serum IgE levels after two and three years of treatment compared with those in the control group ( P<0.05 ) . In conclusion , three-year SCIT treatment combined with ICS is an effective immunotherapy for children with allergic asthma and result ed in a reduction of the required ICS dose Forty‐six asthmatics with verified allergy to the house dust mite , D. pteronyssinus ( Dp ) , participated in a double‐blind study comparing the effect of 2 years ' hyposensitization with two different Dp extracts . Two groups received either monomethoxypolyethylene glycol modified ( mPEG ) Dp extract or the corresponding non‐modified extract , and a third group acted as controls receiving no injections . Medicine consumption , symptom scores , and peak expiratory flow ( PEF ) were recorded daily from September to December prior to and after 6 and 18 months of treatment . Changes were calculated choosing changes 10 % as relevant . In addition , patients were asked to give their direct assessment of the clinical effect at the end of the study . After 6 months , there was an improvement in symptoms + medication in 11/14 of Dp‐treated , 6/17 of the mPEG‐Dp group ( P > 0.05 ) and 3/15 of openly treated controls . Few patients had changed in PEF . During the second year , several Dp‐treated relapsed and some controls improved . At the end of the study the same improvement rate was seen in all groups . Similarly , the retrospective question naire data did not disclose any significant differences between groups after 2 years . In conclusion , hyposensitization with unmodified Dp extract seemed to have a favourable short‐term effect on bronchial symptoms + medication in the majority of patients . When mainly on maintenance dose , the beneficial effect was reduced . The mPEG modification of the extract had reduced not only allergenicity but also the clinical effect of equal doses . Changes in medicine and symptom scores only partly correlated to retrospective assessment , thus stressing the problems in this kind of evaluation A double-blind clinical trial of hyposensitization with aqueous extracts of Dermatophagoides pteronyssinus ( the house-dust mite ) and human skin scales showed a substantial improvement in symptoms in 11 asthmatics allergic to house dust treated with the D. pteronyssinus extract and a reduction in their need for other therapy . Five patients were well for a year but six relapsed . These results contrasted with the generally unfavourable course of the patients treated with the extract of human skin scales . Asthma due to house-dust allergy may be substantially improved by hyposensitization with D. pteronyssinus extract IMPORTANCE The house dust mite ( HDM ) sublingual allergen immunotherapy ( SLIT ) tablet is a potential novel treatment option for HDM allergy-related asthma . OBJECTIVES To evaluate the efficacy and adverse events of the HDM SLIT tablet vs placebo for asthma exacerbations during an inhaled corticosteroid ( ICS ) reduction period . DESIGN , SETTING S , AND PARTICIPANTS Double-blind , r and omized , placebo-controlled trial conducted between August 2011 and April 2013 in 109 European trial sites . The trial included 834 adults with HDM allergy-related asthma not well controlled by ICS or combination products , and with HDM allergy-related rhinitis . Key exclusion criteria were FEV1 less than 70 % of predicted value or hospitalization due to asthma within 3 months before r and omization . Efficacy was assessed during the last 6 months of the trial when ICS was reduced by 50 % for 3 months and then completely withdrawn for 3 months . INTERVENTIONS 1:1:1 r and omization to once-daily treatment with placebo ( n = 277 ) or HDM SLIT tablet ( dosage groups : 6 SQ-HDM [ n = 275 ] or 12 SQ-HDM [ n = 282 ] ) in addition to ICS and the short-acting β2-agonist salbutamol . MAIN OUTCOMES AND MEASURES Primary outcome was time to first moderate or severe asthma exacerbation during the ICS reduction period . Secondary outcomes were deterioration in asthma symptoms , change in allergen-specific immunoglobulin G4 ( IgG4 ) , change in asthma control or asthma quality -of-life question naires , and adverse events . RESULTS Among 834 r and omized patients ( mean age , 33 years [ range , 17 - 83 ] ; women , 48 % ) , 693 completed the study . The 6 SQ-HDM and 12 SQ-HDM doses both significantly reduced the risk of a moderate or severe asthma exacerbation compared with placebo ( hazard ratio [ HR ] : 0.72 [ 95 % CI , 0.52 - 0.99 ] for the 6 SQ-HDM group , P = .045 , and 0.69 [ 95 % CI , 0.50 - 0.96 ] for the 12 SQ-HDM group , P = .03 ) . The absolute risk differences based on the observed data ( full analysis set ) in the active groups vs the placebo group were 0.09 ( 95 % CI , 0.01 - 0.15 ) for the 6 SQ-HDM group and 0.10 ( 95 % CI , 0.02 - 0.16 ) for the 12 SQ-HDM group . There was no significant difference between the 2 active groups . Compared with placebo , there was a reduced risk of an exacerbation with deterioration in asthma symptoms ( HR , 0.72 [ 95 % CI , 0.49 - 1.02 ] for the 6 SQ-HDM group , P = .11 , and 0.64 [ 95 % CI , 0.42 - 0.96 ] for the 12 SQ-HDM group , P = .03 ) and a significant increase in allergen-specific IgG4 . However , there was no significant difference for change in asthma control question naire or asthma quality -of-life question naire for either dose . There were no reports of severe systemic allergic reactions . The most frequent adverse events were mild to moderate oral pruritus ( 13 % for the 6 SQ-HDM group , 20 % for the 12 SQ-HDM group , and 3 % for the placebo group ) , mouth edema , and throat irritation . CONCLUSIONS AND RELEVANCE Among adults with HDM allergy-related asthma not well controlled by ICS , the addition of HDM SLIT to maintenance medications improved time to first moderate or severe asthma exacerbation during ICS reduction , with an estimated absolute reduction at 6 months of 9 to 10 percentage points ; the reduction was primarily due to an effect on moderate exacerbations . Treatment-related adverse events were common at both active doses . Further studies are needed to assess long-term efficacy and safety . TRIAL REGISTRATION clinical trialsregister.eu Identifier : 2010 - 018621 - 19 BACKGROUND Cockroach allergy is a key contributor to asthma morbidity in children living in urban environments . OBJECTIVE We sought to document immune responses to cockroach allergen and provide direction for the development of immunotherapy for cockroach allergy . METHODS Four pilot studies were conducted : ( 1 ) an open-label study to assess the safety of cockroach sublingual immunotherapy ( SLIT ) in adults and children ; ( 2 ) a r and omized , double-blind biomarker study of cockroach SLIT versus placebo in adults ; ( 3 ) a r and omized , double-blind biomarker study of 2 doses of cockroach SLIT versus placebo in children ; and ( 4 ) an open-label safety and biomarker study of cockroach subcutaneous immunotherapy ( SCIT ) in adults . RESULTS The adult SLIT trial ( n = 54 ; age , 18 - 54 years ) found a significantly greater increase in cockroach-specific IgE levels between the active and placebo groups ( geometric mean ratio , 1.92 ; P < .0001 ) and a trend toward increased cockroach-specific IgG4 levels in actively treated subjects ( P = .09 ) but no evidence of functional blocking antibody response . The pediatric SLIT trial ( n = 99 ; age , 5 - 17 years ) found significant differences in IgE , IgG , and IgG4 responses between both active groups and the placebo group but no consistent differences between the high- and low-dose groups . In the SCIT study the treatment result ed in significant changes from baseline in cockroach IgE , IgG4 , and blocking antibody levels . The safety profile of cockroach immunotherapy was reassuring in all studies . CONCLUSIONS The administration of cockroach allergen by means of SCIT is immunologically more active than SLIT , especially with regard to IgG4 levels and blocking antibody responses . No safety concerns were raised in any age group . These pilot studies suggest that immunotherapy with cockroach allergen is more likely to be effective with SCIT Continuing study for a second year and further analysis of a double‐blind placebo controlled trial , already briefly reported , of injections of tyrosine‐adsorbed , glutaraldehyde‐modified Dermatophagoides pteronyssinus antigen in fifty‐one children with perennial asthma and positive bronchial challenge to the antigen , confirms that the patients receiving the treatment reduced their symptomatic medication more than controls , without deterioration of symptoms . Some became symptom‐free , when off all treatment BACKGROUND The safety and efficacy of specific immunotherapy for mold allergy are not known in children and adolescents . OBJECTIVE We evaluated the efficacy and safety of specific immunotherapy with a st and ardized allergen extract in a r and omized , double-blind , placebo-controlled , 3-year prospect i ve study of patients who were allergic to only Alternaria alternata . METHODS Fifty children and adolescents ( 25 girls ; 5 - 18 years of age ) with A alternata-induced seasonal allergic rhinoconjunctivitis and /or bronchial asthma were r and omly assigned to groups given treatment ( Novo-Helisen Depot , A alternata 100 % ) or placebo . The primary end point was the combined symptom medication score . Secondary end points included safety , quality of life , and sensitivity to allergen-specific nasal challenge . RESULTS Forty-five children completed the 3-year study . Although there was no significant change in year 1 , the combined symptom medication score decreased in years 2 and 3 of the study ( by 38.7 % and 63.5 % , respectively ; P < .001 for each ) . The reduction in symptoms was associated with a significant improvement in quality of life ( P < .05 ) and decrease in sensitivity after allergen-specific nasal challenge . Side effects were observed in 7 patients ; the most common ( edema at the site of injection ) occurred after 11 injections . CONCLUSIONS Allergen-specific immunotherapy with st and ardized A alternata extract reduces symptoms of asthma and rhinoconjunctivitis in children and adolescents without serious side effects Hyposensitisation with Dermatophagoides pteronyssinus tyrosine absorbate in asthmatic children with bronchial sensitivity to D. pteronyssinus was effective in a 12-month double-blind controlled clinical trial . Compared with controls , treated children used a smaller quantity of drugs while maintaining clinical and lung function improvements . In most children who improved there was no change in immediate response to D. pteronyssinus on bronchial provocation test , but the late reaction was lost in half the patients and these showed the greatest improvement in symptoms BACKGROUND Cells producing a T(H2)-cytokine profile play an important role in the onset and maintenance of atopic diseases , and therefore specific immunotherapy is aim ed to induce a switch to cells producing a T(H1)- or T(H0)-cytokine profile . Recently , a novel form of immunotherapy making use of synthetic peptides from the major cat allergen Fel d 1 has been developed , but its mechanisms of action are unknown . OBJECTIVES We examined the effects of immunotherapy with Fel d 1 peptides on the response to bronchial provocation tests ( PD20FEV1 ) with a st and ardized Fel d 1 cat extract on Fel d 1-specific serum IgE and IgG levels and in vitro IL-4 and Output:	This was robust to a prespecified sensitivity analyses , but there was evidence suggestive of publication bias . For secondary outcomes , subcutaneous immunotherapy ( SCIT ) improved quality of life and decreased allergen-specific airway hyperreactivity ( AHR ) , but this was not the case for sublingual immunotherapy ( SLIT ) . There were no consistent effects on asthma control , exacerbations , lung function , and nonspecific AHR . AIT result ed in a modest increased risk of adverse events ( AEs ) . Although relatively uncommon , systemic AEs were more frequent with SCIT ; however no fatalities were reported . The limited evidence on cost-effectiveness was mainly available for sublingual immunotherapy ( SLIT ) and this suggested that SLIT is likely to be cost-effective . AIT can achieve substantial reductions in short-term symptom and medication scores in allergic asthma . It was however associated with a modest increased risk of systemic and local AEs .
MS2636	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Although various analgesics have been used , postoperative pain remains one of the most troublesome aspects of tonsillectomy for patients . OBJECTIVE The aim of the present study was to evaluate the effectiveness of premedication using pregabalin compared with placebo ( diazepam ) on postoperative pain control in patients undergoing tonsillectomy . METHODS Forty-eight adult patients were r and omly divided into a control group and a pregabalin group . Preoperatively , patients in the control group received 4 mg diazepam orally as placebo , whereas those in the pregabalin group received 300 mg pregabalin orally . All participants were provided with patient-controlled analgesia using fentanyl for 24 hours after surgery . Postoperative pain treatment included acetaminophen 650 mg three times daily for 8 postoperative days . The primary outcome measure was the total amount of patient-controlled fentanyl consumption after tonsillectomy . Secondary outcome measures were the number of injections of ketorolac tromethamine ( each 30 mg ) requested by patients , pain scores , overall satisfaction scores , drowsiness , nausea , dizziness , headache , and vomiting after the surgery . P < 0.05 was considered statistically significant . RESULTS The total amount of fentanyl dem and ed decreased significantly in the pregabalin group ( P < 0.001 ) . There were no significant differences in the number of ketorolac tromethamine injections , pain scores , overall satisfaction scores , drowsiness , nausea , dizziness , headache , and vomiting between the two groups . CONCLUSION Administration of 300 mg pregabalin prior to tonsillectomy decreases fentanyl consumption compared with that after 4 mg diazepam , without an increased incidence of adverse effects . TRIAL REGISTRATION KCT0001215 STUDY OBJECTIVE To investigate the efficacy of pregabalin for the relief of postoperative shoulder pain after laparoscopic gynecologic surgery . DESIGN Prospect i ve , r and omized , double-blind , placebo-controlled trial ( Canadian Task Force classification I ) . SETTING Tertiary referral center , university hospital . PATIENTS Fifty-six women undergoing elective laparoscopic gynecologic surgery between June 2012 and March 2013 . INTERVENTIONS Women in the study group received 75 mg pregabalin 2 hours before surgery and then every 12 hours for 2 doses , and women in the control group received an identical capsule and the same dosage of placebo . MEASUREMENTS AND MAIN RESULTS Visual analog scale ( VAS ) scores for shoulder pain and surgical pain at 24 and 48 hours after surgery were evaluated as primary outcome . Postoperative analgesics used and drug-related adverse events were also monitored . Patients in the pregabalin group had significantly lower postoperative VAS scores for shoulder pain at 24 hours , compared with the placebo group ( median , 23.14 [ range , 13.67 - 32.61 ] vs. 37.22 [ 27.75 - 46.64 ] ; p = .04 ) , and required less analgesic ( p = .01 ) . There were no significant differences in VAS scores for surgical pain and adverse events between the 2 groups ( p = .56 ) . CONCLUSIONS Perioperative administration of 75 mg pregabalin significantly reduced postoperative laparoscopic shoulder pain and amount of analgesic used Abstract We aim ed to investigate the role of preoperative single dose of pregabalin for attenuating postoperative pain and analgesic consumption in patients undergoing septoplasty . One hundred forty-three patients with ASA physical status I who underwent elective septoplasty were included in this prospect i ve , r and omized , and controlled study . Subjects were r and omized to receive pregabalin 75 mg , pregabalin 150 mg , and control group . All the medications were administered orally 1 hour before surgery . A st and ard septoplasty technique was used for all patients . Postoperative pain intensity was evaluated by a 0- to 100-mm horizontal visual analog scale ( VAS ) ( 0 , no pain ; 100 , worst imaginable pain ) . Total analgesic consumption 1 to 24 h after operation was also recorded . Visual analog scale scores in the 1st , 2nd , 4th , 6th , 12th , and 24th hour were significantly decreased in 75 and 150 mg pregabalin group compared with the control group , and VAS scores in the 12th and 24th hour were significantly decreased in pregabalin 150 mg compared with 75 mg . The 24th total analgesic consumption was significantly decreased in pregabalin 75 mg and 150 mg groups compared with the control group . In conclusion , a single preoperative oral dose pregabalin 75 or 150 mg is an effective method for reducing postoperative pain and total analgesic consumption in patients undergoing septoplasty BACKGROUND Preoperative administration of pregabalin is proposed as a promising way of enhancing postoperative pain control . Whereas a few studies have investigated the effect of pregabalin on postoperative opioid consumption , no study has focused on the influence on postoperative hyperalgesia . In this r and omized , triple-blinded , placebo-controlled study , we aim ed to demonstrate that a single , preoperative dose of pregabalin reduces postoperative opioid consumption , mechanical hyperalgesia , and pain sensitivity . METHODS Patients undergoing elective transperitoneal nephrectomy received 300 mg pregabalin or placebo 1 h before anaesthesia . After operation , patients received piritramide via a patient-controlled analgesia device . Pain levels and side-effects were documented . The area of hyperalgesia for punctuate mechanical stimuli around the incision was measured 48 h after the operation with a h and -held von Frey filament . Mechanical pain threshold was tested before and 48 h after surgery with von Frey filaments with increasing diameters . RESULTS In each group , 13 patients were recruited . Total piritramide consumption [ 77 ( 16 ) vs 52 ( 16 ) mg , P=0.0004 ] and the normalized area of hyperalgesia [ 143 ( 87 ) vs 84 ( 54 ) cm(2 ) , P=0.0497 ] were significantly decreased in the pregabalin group . There were no significant differences in mechanical pain threshold levels [ 1.20 ( 0.56 ) log(g ) vs 1.05 ( 0.58 ) log(g ) , P=0.6738 ] . No case of severe sedation was reported in both groups . No other side-effects were observed . CONCLUSIONS Our study has shown that preoperative administration of 300 mg pregabalin in patients undergoing transperitoneal nephrectomy reduces postoperative opioid consumption and decreases the area of mechanical hyperalgesia Prevention and treatment of postoperative pain continues to be a major challenge in postoperative care . Opioid analgesics , with their well-known side effects , continue to represent a cornerstone in postoperative pain control . Anticonvulsant medications are established treatments for neuropathic pain . Pregabalin ( S-[+]-3-isobutylgaba ) , a structural analog of gamma-Aminobutyric acid , has been used for the treatment of various neuropathic pain and also as an adjunctive therapy for adults with partial onset seizures . This study was thus taken up to primarily assess and compare the analgesic and anxiolytic effects of administering pregabalin and tramadol preoperatively for patients undergoing elective decompressive lumbar laminectomy . The study group included 75 patients between the ages of 20–60 years belonging to American Society of Anesthesiology-1 ( ASA ) and ASA-2 patients . The patients were r and omly allocated into three groups of 25 patients each . The placebo group received a placebo capsule , the tramadol group received a 100 mg capsule , while the pregabalin group received a 150 mg capsule orally 1 hour before anesthetic induction . Pregabalin showed statistically significant analgesic effects compared to placebo , but the effect was found to be less prevalent compared to tramadol . The need for rescue analgesia was the least prevalent in tramadol patients followed by pregabalin patients , and reached a maximum in the control group . Pregabalin showed statistically significant anxiolytic effects compared to placebo , and this was associated with less sedation in comparison to tramadol . Pregabalin had fewer numbers of postoperative complications of nausea , vomiting , and drowsiness in comparison to tramadol . The results of this study support the clinical use of pregabalin in the postsurgical setting for pain relief , as it is well tolerated , and usually presents with transient adverse effects BACKGROUND This was a r and omized , double-blinded clinical trial to study the effects of a single oral dose of pregabalin 150 mg in postoperative pain management after mastectomy . METHODS DESIGN forty nine patients ASA I or II , aged between 20 - 60 years , scheduled for mastectomy with or without axillary lymph nodes dissection ( ALND ) were recruited into this study . They were r and omized into two groups , placebo ( n = 24 ) or pregabalin ( n = 25 ) receiving either oral pregabalin 150 mg or placebo when called to operation theatre ( OT ) . The assessment of pain score were performed at recovery , 2 , 4 , 6 and 24 hours postoperatively at rest and on movement , using the verbal numeral rating score ( VNRS ) . RESULTS VNRS scores for pain at rest were lower in the pregabalin group at 2 ( p = 0.024 ) , 4 ( p = 0.006 ) and 6 ( p = 0.003 ) hours postoperatively , and also at 4 ( p = 0.005 ) and 6 ( p = 0.016 ) hours postoperatively on movement compared to the placebo group . Incidences . of dizziness were common , however , side effects such as nausea and vomiting , headache , somnolence and visual disturbance were low and comparable in both groups . CONCLUSION A single dose of 150 mg pregabalin given preoperatively compared to placebo significantly reduced postoperative pain scores after mastectomy BACKGROUND AND OBJECTIVES Adding novel adjunctive drugs like gabapentinoids to multimodal analgesic regimen might be reasonable for lessening postoperative pain scores , total opioid consumption and side effects after percutaneous nephrolithotomy . We aim ed to evaluate the effect of pregabalin on postoperative pain scores , analgesic consumption and renal functions expressed by creatinine clearance ( CrCl ) and blood neutrophil gelatinase-associated lipocalin ( NGAL ) and cystatin C ( Cys C ) levels in patients undergoing percutaneous nephrolithotomy ( PCNL ) . METHODS 60 patients undergoing elective PCNL were enrolled in the study . Patients were r and omized to oral single dose 75 mg pregabalin group and a control group . Visual Analog Scale pain scores ( VAS ) , postoperative intravenous morphine consumption during the first 24 postoperative hours , serum NGAL , Cys C levels and creatinine clearance ( CrCl ) was measured preoperatively and post-operatively at 2nd and 24th hour . RESULTS Postoperative VAS scores were significantly decreased in the pregabalin group at the postoperative 30th min , 1st , and 2nd hour ( p = 0.002 , p = 0.001 and p = 0.027 , respectively ) . Postoperative mean morphine consumption was statistically significantly decreased for all time intervals in the pregabalin group ( p = 0.002 , p = 0.001 , p = 0.001 , p = 0.001 , p < 0.001 , respectively ) . No statistically significant differences were found between the two groups with regard to CrCl , or Cys C at preoperative and postoperative 2nd and 24th hour . Postoperative 24th hour NGAL levels were significantly decreased in the pregabalin group ( p = 0.027 ) . CONCLUSIONS Oral single-dose preemptive 75 mg pregabalin was effective in reducing early postoperative pain scores and total analgesic consumption in patients undergoing PCNL without leading to hemodynamic instability and side effects INTRODUCTION Gabapentin and pregabalin have been compared in studies conducted on management of neuropathic and postoperative pain . In neuropathic pain studies , the analgesic effects of the two drugs were compared , and pregabalin has been found to be more potent . However , in postoperative pain studies , the effects of each drug were examined separately . This study compared the analgesic effects of pregabalin ( 300 mg day-1 ) , gabapentin ( 1,200 mg day-1 ) and a placebo in managing postoperative pain following laminectomy and discectomy . METHODS 90 patients were r and omly assigned to three groups ( pregabalin , gabapentin and placebo ) of 30 patients each . Pregabalin 150 mg , gabapentin 600 mg and a placebo were administered every 12 hours , two times pre- and post surgery . Study data collected included morphine consumption , Visual Analogue Scale records , preoperative anxiety , patient satisfaction , adverse effects and observation notes . RESULTS In the gabapentin and pregabalin groups , overall morphine consumption , preoperative anxiety , pruritus , postoperative shivering were significantly lower Output:	The primary outcomes were 24 h morphine i.v . Based on trials with low risk of bias , pregabalin may have a minimal opioid-sparing effect , but the risk of SAEs seems increased .
MS2637	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: INTRODUCTION Since 1994 we perform laparoscopic total extraperitoneal hernia repair ( TEP ) for primary and recurrent inguinal hernias at our institution . The aim of this study was to investigate and compare the results of TEP in primary inguinal hernias and recurrent inguinal hernias and to determine whether there are differences in patient data , complication rates and outcome between these two groups . METHODS In a prospect i ve trial 338 patients were analyzed who underwent 500 laparoscopic TEP repairs . In all , 431 TEP repairs were performed for primary inguinal hernias , and 69 for recurrent inguinal hernias . For data acquisition the SALTC study protocol was used . All patients were clinical ly examined 3 and 12 months after the operation . RESULTS The mean operation time was 67.3 min for TEP repair of primary hernias and 68.1 min for TEP repair of recurrent hernias , respectively . The conversion rate to an open procedure was 0 % . Conversion from TEP into TAPP was required in 0.5 % of patients with primary inguinal hernias and 1.4 % of patients with recurrent inguinal hernias . As the sole difference between the two groups the intraoperative complication rate could be identified . In the TEP repair group of recurrent inguinal hernias a higher incidence of injury to the peritoneum and a higher occurrence of bleeding from the epigastric vessels was found ( P = 0.03 ) . The postoperative complication rate was identical in the two groups , amounting to 5.1 % and 5.7 % , respectively . No differences were found in the 1 year follow-up between the two groups . The 1-year recurrence rate was 0.5 % for primary hernias . However , in the group of recurrent hernias there have been no recurrences to date . CONCLUSIONS The use of laparoscopic TEP repair has proven to be a safe and effective treatment in patients with primary and recurrent inguinal hernias . Because of scar tissue with possible adhesions a higher intraoperative complication rate was observed in the TEP repair of recurrent hernias than in TEP repair of primary inguinal hernias . However , no single recurrence was observed in the TEP repair group of recurrent hernias . In our opinion TEP is the optimal hernia repair for recurrent and bilateral inguinal hernias BACKGROUND For many years it has been cl aim ed that observational studies find stronger treatment effects than r and omized , controlled trials . We compared the results of observational studies with those of r and omized , controlled trials . METHODS We search ed the Abridged Index Medicus and Cochrane data bases to identify observational studies reported between 1985 and 1998 that compared two or more treatments or interventions for the same condition . We then search ed the Medline and Cochrane data bases to identify all the r and omized , controlled trials and observational studies comparing the same treatments for these conditions . For each treatment , the magnitudes of the effects in the various observational studies were combined by the Mantel-Haenszel or weighted analysis -of-variance procedure and then compared with the combined magnitude of the effects in the r and omized , controlled trials that evaluated the same treatment . RESULTS There were 136 reports about 19 diverse treatments , such as calcium-channel-blocker therapy for coronary artery disease , appendectomy , and interventions for subfertility . In most cases , the estimates of the treatment effects from observational studies and r and omized , controlled trials were similar . In only 2 of the 19 analyses of treatment effects did the combined magnitude of the effect in observational studies lie outside the 95 percent confidence interval for the combined magnitude in the r and omized , controlled trials . CONCLUSIONS We found little evidence that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or qualitatively different from those obtained in r and omized , controlled trials Background : A variety of procedures with substantial differences in results are employed to treat recurrent inguinal hernia . The advantages of totally extraperitoneal patch repair ( TEP ) are even more evident when it is applied to recurrent compared to primary hernias . To investigate the superiority of this method more closely , we review ed our results obtained for recurrent inguinal hernias over a period of 2 years . Methods : We performed a prospect i ve single-center study using data obtained in consecutive patients with recurrent inguinal hernia who were operated on in 1997 and 1998 . Results : A total of 179 patients with recurrent inguinal hernia were recruited . Overall , 1329 patients with inguinal hernia were treated in the 2-year period , of whom 1270 underwent TEP . The percentage of recurrent hernias was 14 % . The average age of the patients was 56 years . The follow-up rate was 87.5 % , and the mean follow-up period was 2.3 years . The 154 patients who were followed up underwent a total of 225 hernia repairs , of which 181 were for recurrent hernias . The average operating time was 57 min . In 68 % ( 104/154 ) of the patients , adhesions , adherent epigastric vessels , or cicatricial changes were found , which result ed in the inadvertant opening of the peritoneum in 26.3 % of the patients . All the openings in the peritoneum were closed by endoscopic suturing . Intraoperative complications developed in 4 patients ( 2.3 % ) , including one injury to the bladder and three cases of bleeding from side branches of the epigastric vessels . The conversion rate was 0 % . The sole postoperative complication was treatment requiring hematomas in 7 patients , in 2 of whom reoperation became necessary . In both cases , a diffuse hemorrhage due to a preoperatively undiagnosed coagulation disorder was found . No cases of wound or patch infection were observed . In a patient undergoing both primary and recurrent hernia repair , displacement of a mesh led to a recurrence on the primary hernia side ( recurrence rate , 0.4 % ; re-recurrence rate , 0 % ) . Conclusions : Although for its definitive management , recurrent hernia requires a reliable operative technique , current data do not support the recommendation of any of the currently available procedures as the gold st and ard . In a representative patient population with recurrent hernia , we were able to demonstrate that TEP achieves very good results in terms of re-recurrence rate , intraoperative and postoperative complications , and rehabilitation . Prerequisites for the reliable and low-complication application of the method are a high level of st and ardization of the procedure and an advanced learning curve Evidence -based medicine ( EBM ) ranks different medical research methods on a hierarchy , at the top of which are r and omized controlled trials ( RCTs ) and systematic review s or meta-analyses of RCTs . Any study that does not r and omly assign patients to a treatment or a control group is automatically placed at a lower level on the hierarchy . This article argues that what matters is whether the treatment and control groups are similar with respect to potential confounding factors , not whether they got that way through r and omization . Moreover , nonr and omized studies tend to have other characteristics that make them useful sources of evidence , in that they tend to last longer and to enroll more patients than do r and omized trials . Replacing the sharp dichotomy between r and omized and nonr and omized studies with a continuum from “ clean ” studies ( which have high internal validity but whose results do not readily generalize to clinical practice ) to pragmatic studies ( which are design ed to more closely reflect clinical practice ) would also make a place for outcomes research and research using clinical data bases , which are not included in the current hierarchy of evidence but which can provide important information about the safety and efficacy of treatments Background : The aim of this study was to investigate the outcome of preperitoneal repair using laparoscopic ( TEP ) and open ( OPM ) approach in recurrent inguinal hernia . Methods : We performed a prospect i ve controlled nonr and omized clinical study in 188 patients with 207 recurrent inguinal hernias over a period of 5 years . TEP repair was employed for 86 repairs , and OPM was used in 121 procedures . The main outcome measurements were : recurrence rate , operating time , hospital stay , and postoperative complications . Results : There were three recurrences ( 1.7 % ) . Two in the OPM group ( 1.8 % ) and one ( 1.3 % ) in the TEP group [ P = NS ( not significant ) ] . The TEP procedure was faster than OPM for unilateral repair ( 40.8 vs 46.3 min ) ( P<0.001 ) . Postoperative complications were more frequent in the OPM group ( 23.9 % ) than the TEP group ( 13.9 % ) ( P = NS ) . Hospital stay was significantly shorter in the TEP group ( 1.2 vs 3.9 days ) ( P<0.001 ) . Conclusions : Preperitoneal approach ( open or laparoscopic ) seems to be a good option in recurrent inguinal hernia when these procedures are done by experienced surgeons Introduction The Lichtenstein hernioplasty for the repair of primary inguinal hernia in male patients is well established and constitutes the current gold st and ard . However a gold st and ard technique for the repair of recurrent inguinal hernia has not been established . The aim of this study was to analyze the outcomes of Lichtenstein hernioplasty for the repair of primary inguinal hernia and recurrent inguinal hernia , applying for that purpose the Qualitative and Quantitative Measurement Instrument ( QQMI ) . Methods We studied 75 recurrent inguinal hernia patients and 287 primary inguinal hernia patients with a follow-up period ranging from 60 to 107 months . Results The final QQMI score demonstrated that most patients in both groups reached scores between 8 and 11 points , with a significant difference in the maximum score ( 11 points ) favoring primary hernia patients . Conclusions All evaluated parameters showed better outcomes in primary hernia patients . Applying the QQMI , we have demonstrated that the outcomes of Lichtenstein hernioplasty are not similar between primary and recurrent inguinal hernia ; there is a tendency toward better outcomes for primary inguinal hernia patients , although the Lichtenstein hernioplasty st and s as a safe option for repair of recurrent inguinal hernias Objective : To compare the Lichtenstein hernioplasty with a totally extraperitoneal preperitoneal laparoscopic technique ( TEP ) in treatment of recurrent inguinal hernias . Summary Background Data : Only a few studies thus far have compared an open and laparoscopic approach with the treatment of recurrent inguinal hernia in a prospect i ve r and omized study setting . Methods : Ninety-nine patients undergoing surgery for recurrent inguinal hernia were prospect ively r and omized into having either open or laparoscopic mesh repair . Pre , peri- and postoperative factors were recorded in addition to 3-year follow-up data at the outpatient clinic . At 5–10 years , the patients were interviewed via telephone for recurrent symptoms . The primary end-points chosen were hernia recurrence and chronic pain . Results : Preoperative factors did not differ between the 2 groups . Rerecurrence rates were 3 in the Lichtenstein group and none in the TEP group ( 6.4 % versus 0.0 % , respectively ) , but this difference was statistically not significant . Chronic pain was more prevalent in the Lichtenstein group compared with the TEP group ( 13 [ 27.7 % ] versus 4 [ 8.2 % ] patients , respectively , P = 0.02 ) . Postoperatively , the Lichtenstein group needed more pain medication than the TEP group ( 4.4 versus 3.0 doses , respectively , P = 0.02 ) and returned to work later ( 17.9 versus 14.8 days , respectively , P = 0.05 ) . Conclusions : The laparoscopic technique with mesh in the treatment of recurrent inguinal hernia was proven superior to the open mesh repair in several important clinical aspects , with concomitant improvement in patient satisfaction Background Recurrences continue to be seen after repair of inguinal hernias . The repair of these recurrent hernias is a more complex and dem and ing procedure , with a high re-recurrence rate . Definite advantage has been demonstrated with endoscopic repair of these hernias . Methods The results for this prospect i ve study from January 2003 to December 2006 were evaluated after laparoscopic repair of 65 recurrent hernias in 61 patients . The patients were followed up for 1 year . Longer follow-up evaluation was performed for the patients who underwent surgery in the initial 3 years . Results In this study , 37 recurrent hernias were managed using the transabdominal preperitoneal technique ( TAPP ) technique and 28 using the totally extraperitoneal ( TEP ) technique . There was no conversion and no cases of postoperative wound infection . Of the 12 metachronous hernias repaired simultaneously , 3 were occult . Seroma developed in five patients . At a follow-up assessment after 1 year , one patient had groin pain , and there was one re-recurrence . A longer follow-up period with a mean of 35.11 months failed to show any new re-recurrence . Conclusions Laparoscopic repair of recurrent inguinal hernia is safe and effective . The morbidity and recurrence rates for the procedure are as low as for laparoscopic repair of primary hernias . Laparoscopic repair should be the gold st and ard for these hernias Background The optimal treatment for recurrent inguinal hernia is of concern due to the high frequency of recurrence . Methods This r and omized multicenter study compared the short- and long-term results for recurrent inguinal hernia repair by either the laparoscopic transabdominal Output:	Comparisons of all outcomes in N RCTs and RCTs failed to show statistical significance . Prospect ive/retrospective cohort studies , case series , and RCTs did not differ significantly in their estimates . Adjusted testing for metaregression disclosed that rerecurrence among N RCTs was independent of the study design . The number of included patients and study setting were independent predictors of outcome .
MS2638	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: RATIONALE Inhaled tobramycin has been shown to transiently clear Pseudomonas from lower airways in early cystic fibrosis ( CF ) , but does not markedly reduce lung inflammation , a key factor in disease progression . OBJECTIVE Test the hypothesis that systemic antibiotics are more effective than inhaled antibiotics for reducing lower airways inflammation . METHODS Clinical ly stable CF children with recent Pseudomonas were r and omized to receive 4 weeks of inhaled tobramycin or 2 weeks of systemic antibiotics ( intravenous ceftazidime and tobramycin ) . Bronchoalveolar lavage fluid was obtained just before and 4 - 6 weeks after treatment . The primary outcome was change in % neutrophils in lavage fluid . RESULTS Fifteen subjects ( inhaled = 6 , systemic = 9 ) completed the protocol . Three Systemic Group subjects could not have central venous access established and were treated with oral ciprofloxacin ( plus inhaled tobramycin ) for 2 weeks as an alternative " systemic " regimen , per protocol . Groups were well matched in age , markers of disease severity , and initial % neutrophils . The Systemic Group showed a modest median change in percent neutrophils ( -7 % ) which was not statistically significant compared to inhaled ( + 5.4 % , P = 0.07 ) . However , the Systemic Group had significantly greater reductions in total cells ( -50 % vs. -3 % , P < 0.01 ) and neutrophils ( -74 % vs. -10 % , P = 0.02 ) per ml lavage fluid . Both groups had reduced bacterial quantity after treatment , but there was no significant difference between groups . CONCLUSIONS In clinical ly stable children with CF , systemic antibiotics result in greater short-term reduction in lower airways inflammation than inhaled antibiotics ABSTRACT The present multicenter , r and omized crossover study compared the safety and efficacy of continuous infusion with those of short infusions of ceftazidime in patients with cystic fibrosis . Patients with chronic Pseudomonas aeruginosa colonization received two successive courses of intravenous tobramycin and ceftazidime ( 200 mg/kg of body weight/day ) for pulmonary exacerbation administered as thrice-daily short infusions or as a continuous infusion . The primary endpoint was the variation in the forced expiratory volume in 1 s ( FEV1 ) during the course of antibiotic treatment . Sixty-nine of the 70 patients enrolled in the study received at least one course of antibiotic treatment . The improvement in FEV1 at the end of therapy was not statistically different between the two treatment procedures ( + 7.6 % after continuous infusion and + 5.5 % after short infusions ) but was better after continuous ceftazidime treatment in patients harboring resistant isolates ( P < 0.05 ) . The interval between the course of antibiotic treatments was longer after the continuous infusion than after the short infusion of ceftazidime ( P = 0.04 ) . The mean serum ceftazidime concentration during the continuous infusion was 56.2 ± 23.2 μg/ml ; the mean peak and trough concentrations during the short infusions were 216.3 ± 71.5 and 12.1 ± 8.7 μg/ml , respectively . The susceptibility profiles of the P. aeruginosa isolates remained unchanged and were similar for both regimens . Quality -of-life scores were similar whatever the treatment procedure , but 82 % of the patients preferred the continuous-infusion regimen . Adverse events were not significantly different between the two regimens . In conclusion , the continuous infusion of ceftazidime did not increase its toxicity and appeared to be as efficient as short infusions in patients with cystic fibrosis as a whole , but it gave better results in patients harboring resistant isolates of P. aeruginosa Purpose : We hypothesized that a single intravenous ( iv ) tobramycine infusion ( treatment B ) would have equivalent anti-infectious efficacy in chronic Pseudomonas aeruginosa ( PA ) infection in cystic fibrosis ( CF ) as the commonly performed treatment of three doses ( treatment A ) . Toxicity and practicability may even be improved in the single-dose regimen . Methods : This was a r and omized crossover study comparing outcome after 14 and 35 days . The primary end-point was a decrease in the leukocyte count , and the secondary end-points were clinical and lung function parameters , Pseudomonas quantification in sputum , and inflammation markers ( immunoglobulin G , C-reactive protein ) in serum . 30 patients ( 20 female , mean age 11.2 years , mean age range 1.7–18.1 years ) received elective 14-day courses of treatments A or B , followed by the alternative treatment after a mean interval of 37 ( ± 21 ) weeks . Results : With the exception of PA density , there were no significant differences between both treatment strategies after 14 days of treatment . After 35 days of treatment , there were no significant changes in the leukocyte count and inflammation markers . Both treatment strategies reduced the bacterial load in the airways , as reflected by a decreased PA density in sputum . Nephrotoxicity was equal in both groups , with a transient slight elevation of urinary N-acetyl-β-glucosaminidase concentrations . St and ard audiometry tests revealed no evidence of a hearing impairment in any patient following therapy . Mean body weight increased during the study period by 0.5 kg . Forced expiratory volume increased by approximately 5 % of the predicted volume , forced vital capacity increased by 2 % of predicted capacity , and forced mid expiratory flow rate increased by 7 % ( A ) or 4 % ( B ) of the predicted normal value , although these changes were not statistically significant . Conclusion : We conclude that tobramycin given in a daily single dose ( with the advantage of being more practical in a home environment ) has an efficacy equal to that of three daily doses in terms of elective antipseudomonal therapy in clinical ly stable patients with CF To evaluate whether the addition of an aminoglycoside might enhance the clinical efficacy of ceftazidime in cystic fibrosis patients with acute exacerbations of chronic Pseudomonas lung infections we carried out a prospect i ve , comparative , r and omized blind study with three schedules : ceftazidime vs. ceftazidime plus sisomicin ( C/S ) vs. piperacillin plus sisomicin , for a total of 60 courses of 14 days of treatment . Each treatment led to clinical and radiologic improvement with marked reduction of signs of acute infection . Statistically there was no significant difference in clinical responses among the schedules . No side effect appeared during treatments with ceftazidime or C/S. Hyperpyrexia was seen in 35 % of patients receiving piperacillin . Decrease in Pseudomonas aeruginosa count to less than 10(5 ) colony-forming units/ml of sputum was achieved in 60 % of patients treated with C/S and in 30 % of patients who received ceftazidime or piperacillin plus sisomicin ( statistically not significant ) . A transient increase in mean geometric minimal inhibitory concentrations for ceftazidime and piperacillin was observed at the end of the combined therapies . A larger percentage of persistent resistant strains of P. aeruginosa was seen after the combined therapies . We conclude that ceftazidime as monotherapy may be an effective alternative in Pseudomonas lung infections in cystic fibrosis patients . Its clinical efficacy seems not to be enhanced by the addition of an aminoglycoside , although reduction of Pseudomonas in the sputum was better achieved by the combination of Thirteen patients with cystic fibrosis ( aged 11 to 32 years ) who were hospitalized for exacerbation and who had sputum cultures positive for Pseudomonas organisms were treated initially for 4 days with bronchodilators and physiotherapy followed by the addition of antibiotic ( 14 days , n = 8) or placebo ( 14 days , n = 4 ; 7 days , n = 1 ) . Tc-99 m DTPA aerosol scintigraphy was performed on the day before bronchodilators and physiotherapy , on the day before antibiotic or placebo , and on the day after completion of antibiotic or placebo therapy . Scintigrams were evaluated for change in the number of nonventilated segments and change in the number of bronchial deposits of aerosol . Sixty-nine percent of patients showed improvement after bronchodilators and physiotherapy alone . Sixty-two percent showed further improvement after antibiotic or placebo was added ; this improvement was independent of whether antibiotic or placebo was administered ( P > 0.1 ) . These aerosol scintigraphy results failed to demonstrate that the effectiveness of bronchodilators and physiotherapy is enhanced by antibiotics in the treatment of cystic fibrosis exacerbations The aim of this study was to test the equivalence of once- and thrice-daily dosing with tobramycin by comparing efficacy and safety in adult patients with cystic fibrosis . Sixty adult patients with an acute respiratory exacerbation were r and omized to receive either 10 mg·kg−1 tobramycin once-daily or 3.3 mg·kg−1 tobramycin thrice-daily . Primary efficacy and safety endpoints were defined as changes in respiratory function and changes in renal function and hearing . Both groups showed a significant increase in respiratory function without a clinical ly significant change in renal function . For changes in forced vital capacity % predicted and serum potassium and magnesium levels , equivalence was demonstrated . For the variables forced expiratory volume in one second and forced mid-expiratory flow % pred and serum creatinine levels , there was insufficient power to demonstrate equivalence . One patient in each group showed bilateral impairment in pure tone audiogram after treatment . This study demonstrated significant clinical improvement with both once- and thrice-daily tobramycin dosing . Equivalence between the two regimens was shown for some , but not all primary endpoints . Once-daily dosing should be used with careful monitoring of safety and efficacy until large multicentre studies confirm these encouraging results ABSTRACT Linezolid is a treatment option for methicillin-resistant Staphylococcus aureus ( MRSA ) infections in cystic fibrosis ( CF ) patients . Little is known , however , about its pharmacokinetics in this population . Eight adults with CF were r and omized to receive intravenous ( i.v . ) and oral linezolid at 600 mg twice daily for 9 doses in a crossover design with a 9-day washout . Plasma sample s were collected after the first and ninth doses of each phase . Population pharmacokinetic analyses were performed by nonlinear mixed-effects modeling using a previously described 2-compartment model with time-dependent clearance inhibition . Monte Carlo simulation was performed to assess the activities of the linezolid dosing regimens against 42 contemporary MRSA isolates recovered from CF patients . The following pharmacokinetic parameter estimates were observed for the population : absorption rate constant , 1.91 h−1 ; clearance , 9.54 liters/h ; volume of central compartment , 26.8 liters ; volume of peripheral compartment , 17.3 liters ; and intercompartmental clearance , 104 liters/h . Linezolid demonstrated nonlinear clearance after 9 doses , which was reduced by a mean of 38.9 % ( range , 28.8 to 59.9 % ) . Mean bioavailability was 85 % ( range , 47 to 131 % ) . At steady state , 600 mg given twice daily produced 93.0 % and 87.2 % probabilities of obtaining the target pharmacodynamic exposure against the MRSA isolates for the i.v . and oral formulations , respectively . Thrice-daily dosing increased the probabilities to 97.0 % and 95.6 % , respectively . Linezolid pharmacokinetics in these adults with CF were well described by a 2-compartment model with time-dependent clearance inhibition . St and ard i.v . and oral dosing regimens should be sufficient to reliably attain pharmacodynamic targets against most MRSA isolates ; however , more frequent dosing may be required for isolates with MICs of ≥2 μg/ml Aminoglycosides are often prescribed as part of the treatment regimen for acute pulmonary exacerbations due to their potent activity and low potential for development of resistance . Preliminary evidence from r and omized controlled trials in patients with cystic fibrosis ( CF ) suggests that once-daily administration of aminoglycosides results in similar efficacy and a low risk for toxicity compared with traditional dosing . The pharmacokinetics of aminoglycosides administered once daily in CF patients are currently not well described . In this study we compare the distribution and elimination patterns of traditional dosing ( 3.3 mg/kg q8h ) versus once-daily dosing ( 10 mg/kg q24h ) of tobramycin in six adult patients with CF . The pharmacokinetics of tobramycin administered either once daily or every 8 h were best described by a two-compartment model . No statistically significant differences in any of the pharmacokinetic parameter values between regimens were noted . The distribution phase half-lives of 32 and 24 min following the q8h and q24h regimens were longer than expected . The use of a one-compartment model requires clinical peak levels to be drawn 2 h after initiation of either a 30 min infusion for multiple daily dosing or a 60 min infusion with once-daily dosing , to ensure completion of the distribution phase . Our data indicate that a dose of Output:	There was a wide variation in the individual antibiotics used in each trial .
MS2639	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Laparoscopy-assisted colectomy istechnically feasible , but objective evidence of its benefits remainsscarce . This study was done to evaluate the outcomes and operativestress of laparoscopy-assisted colectomy versus the traditional open method in the management of sigmoid complex polyps that can not besafely or adequately removed by colonofibroscopy . Between January 1997 and December 1999 , a total of 42 patients were equally r and omizedto the laparoscopy group and the laparotomy group by the blockedr and omization method . Three patients r and omized to the laparoscopygroup did not complete the trial ; therefore 18 patients treated bylaparoscopy-assisted sigmoidectomy and the other 21 treated by the open method were prospect ively evaluated . These two groups of patients werewell matched in age , gender , symptoms , tumor location , localization method , tumor size , morphology , histopathology , and the accuracy of the clinical diagnosis . Two st and ardized surgical strategies , thelateral-to-medial and medial-to-lateral dissection sequences , wereperformed in 14 and 4 patients of the laparoscopy group , respectively , according to whether their tumors were located above or below 20 cmabove the anal verge . After evaluating the surgical outcomes , we foundthat the laparoscopy group was significantly better than the laparotomygroup in regard to parameters that included severity of postoperativepain , wound size , postoperative complication rate , and the duration ofpostoperative ileus , hospitalization , and disability . There was nosignificant difference in the operating times for these two groups . However , the costs of the laparoscopy group were significantly higher . To evaluate the surgical stress , we measured the serum C-reactiveprotein ( CRP ) level , erythrocyte sedimentation rate ( ESR ) , totallymphocyte count , and CD4+/CD8 + ratio 24 hoursbefore and after surgery . We found that the postoperative serum CRPlevel and the ESR were significantly less elevated and the totallymphocyte counts and CD4+/CD8 + ratio weresignificantly less depressed in the laparoscopy group than in thelaparotomy group . We thus concluded that laparoscopy-assistedsigmoidectomy can be safely performed with shorter convalescence and less operative stress but at a higher cost . We strongly recommended theuse of this technique in the management of sigmoid complex polyps ifthe patient 's economic status permits CONTEXT Laparoscopic-assisted colectomy ( LAC ) has emerged as the preferred minimally invasive surgical strategy for diseases of the colon . The safety and efficacy of LAC for colon cancer are unknown , and the nature and magnitude of any quality -of-life ( QOL ) benefit result ing from LAC for colon cancer is also unknown . OBJECTIVE To compare short-term QOL outcomes after LAC vs open colectomy for colon cancer . DESIGN , SETTING , AND PARTICIPANTS Multicenter , r and omized controlled trial ( Clinical Outcomes of Surgical Therapy [ COST ] ) . Between September 1994 and February 1999 , 37 of 48 centers provided data for the QOL component of the trial for 449 consecutive patients with clinical ly resectable colon cancer . MAIN OUTCOME MEASURES Scores on the Symptoms Distress Scale ( SDS ) , Quality of Life Index , and a single-item global rating scale at 2 days , 2 weeks , and 2 months postoperative ; duration of postoperative in-hospital analgesic use ; and length of stay . RESULTS Of 449 patients , 428 provided QOL data . In an intention-to-treat analysis comparing SDS pain intensity , SDS summary , QOL Index summary , and global rating scale scores at each time point , the only statistically significant difference observed between groups was the global rating scale score for 2 weeks postsurgery . The mean ( median ) global rating scale scores for 2 weeks postsurgery were 76.9 ( 80 ) for LAC vs 74.4 ( 75 ) for open colectomy ( P = .009 ) . While in the hospital , patients assigned to LAC required fewer days of both parenteral analgesics compared with patients assigned to open colectomy ( mean [ median ] , 3.2 [ 3 ] vs 4.0 [ 4 ] days ; P<.001 ) and oral analgesics ( mean [ median ] , 1.9 [ 1 ] vs 2.2 [ 2 ] days ; P = .03 ) . CONCLUSION Only minimal short-term QOL benefits were found with LAC for colon cancer compared with st and ard open colectomy . Until ongoing trials establish that LAC is as effective as open colectomy in preventing recurrence and death from colon cancer , this procedure should not be offered to patients with colon cancer Background : The magnitude of surgical trauma after laparoscopic and open colonic resection was evaluated by examining postoperative serum values of interleukin-6 ( IL-6 ) , IL-10 , C-reactive protein ( CRP ) , and granulocyte elastase ( GE ) for further evidence of the benefit realized with minimally invasive approaches in colonic surgery . Methods : Altogether , 42 patients with Crohn 's disease ( n = 20 ) or colon carcinomas/adenomas ( n = 22 ) were matched by age , gender , body mass index ( BMI ) , and Crohn 's Disease Activity Index for either a laparoscopic ( n = 21 ) or an open colonic resection ( n = 21 ) . In both groups the postoperative serum levels of IL-6 , IL-10 , C-RP , and granulocyte elastase were determined , as indicators of surgical stress . Results : Laparoscopic and open colonic resection caused a significant increase in serum IL-6 , IL-10 , CRP , and granulocyle elastase levels . The comparison between laparoscopic and open colonic resections , however , showed significantly lower serum IL-6 , IL-10 , CRP , and granulocyte elastase levels after laparoscopic colonic resection , which was most evident for IL-6 and granulocyte elastase . Conclusions : Our study demonstrated that IL-6 and granulocyte elastase may be appropriated particularly to monitor surgical stress . By using these parameters , we found a significant reduction in surgical trauma after laparoscopic surgery , was compared with the open procedure . This supports the clinical findings of a clear benefit for patients undergoing laparoscopic colonic surgery Background : A shorter duration of postoperative ileus and earlier oral alimentation of patients may be a clinical ly relevant benefit of laparoscopic compared with conventional colorectal resection . Patients / Methods : A total of 60 patients were r and omised to either laparoscopic ( n=30 ) or conventional ( n=30 ) resection of colorectal tumours . Major endpoints were the postoperative time to the first bowel movement and the time until oral feeding without parenteral alimentation was tolerated . Minor endpoints were the postoperative interval to the first peristalsis and first passage of flatus , the distribution of radio-opaque markers in abdominal radiographs on day 3 and day 5 and the incidence of postoperative vomiting . Results : Age , gender , ASA-classification and type of resection were comparable in thetwo groups . Peristalsis was first noticed 26±9 h after laparoscopic and 38±17 h after conventional colorectal resection ( P<0.01 ) . First flatus occurred 50±19 h after laparoscopic and 79±21 h after conventional surgery ( P<0.01 ) . The incidence of postoperative vomiting was similar in both groups . Three days after surgery radio-opaque markers were found more often in the right colon ( P<0.01 ) and less often in the small intestine ( P<0.05 ) in laparoscopic compared with conventional patients . Five days after laparoscopic surgery , more markers had reached the left colon ( P<0.05 ) . The first bowel movement occurred 70±32 h after laparoscopic and 91±22 h after conventional resection ( P<0.01 ) . Oral feeding without additional parenteral alimentation was tolerated 3.3±0.7 days after laparoscopic and 5.0±1.5 days after conventional surgery ( P<0.01 ) . Conclusion : The shorter duration of postoperative ileus allows earlier restoration of oral feeding after laparoscopic compared with conventional colorectal resection and therefore increases quality of life immediately after resection of colorectal tumours BACKGROUND Minimally invasive , laparoscopically assisted surgery was first considered in 1990 for patients undergoing colectomy for cancer . Concern that this approach would compromise survival by failing to achieve a proper oncologic resection or adequate staging or by altering patterns of recurrence ( based on frequent reports of tumor recurrences within surgical wounds ) prompted a controlled trial evaluation . METHODS We conducted a noninferiority trial at 48 institutions and r and omly assigned 872 patients with adenocarcinoma of the colon to undergo open or laparoscopically assisted colectomy performed by credentialed surgeons . The median follow-up was 4.4 years . The primary end point was the time to tumor recurrence . RESULTS At three years , the rates of recurrence were similar in the two groups--16 percent among patients in the group that underwent laparoscopically assisted surgery and 18 percent among patients in the open-colectomy group ( two-sided P=0.32 ; hazard ratio for recurrence , 0.86 ; 95 percent confidence interval , 0.63 to 1.17 ) . Recurrence rates in surgical wounds were less than 1 percent in both groups ( P=0.50 ) . The overall survival rate at three years was also very similar in the two groups ( 86 percent in the laparoscopic-surgery group and 85 percent in the open-colectomy group ; P=0.51 ; hazard ratio for death in the laparoscopic-surgery group , 0.91 ; 95 percent confidence interval , 0.68 to 1.21 ) , with no significant difference between groups in the time to recurrence or overall survival for patients with any stage of cancer . Perioperative recovery was faster in the laparoscopic-surgery group than in the open-colectomy group , as reflected by a shorter median hospital stay ( five days vs. six days , P<0.001 ) and briefer use of parenteral narcotics ( three days vs. four days , P<0.001 ) and oral analgesics ( one day vs. two days , P=0.02 ) . The rates of intraoperative complications , 30-day postoperative mortality , complications at discharge and 60 days , hospital readmission , and reoperation were very similar between groups . CONCLUSIONS In this multi-institutional study , the rates of recurrent cancer were similar after laparoscopically assisted colectomy and open colectomy , suggesting that the laparoscopic approach is an acceptable alternative to open surgery for colon cancer INTRODUCTION : Surgeons have been reluctant to apply laparoscopic techniques to Crohn 's disease surgery because of concerns with evaluating and excising inflamed tissue using laparoscopic methods Additionally in Crohn 's disease surgery , laparoscopic techniques have not been demonstrated to have clear advantages over conventional ones . METHOD : We conducted a prospect i ve , r and omized trial in one surgical department comparing laparoscopic vs. conventional techniques in 60 patients ( 25 males ) , median age 34.4 ( range 10–60.1 ) years , undergoing elective ileocolic resection for refractory Crohn 's disease . Postoperatively , all patients underwent measurement of pulomnary function tests every 12 hours , and were treated identically on a highly controlled protocol with regard to analgesic administration , feeding , and postoperative care . RESULTS : Of the 31 patients assigned to laparoscopic and 29 to the conventional group , all had isolated Crohn 's disease of the terminal ileum plus or minus the cecum . Median length of the incision was 5 cm in the laparoscopic group and 12 cm in the conventional group . Overall recovery of 80 percent of forced expiratory volume ( one second ) and forcec vital capacity was a median of 2.5 days for laparoscopic and 3.5 days for conventional ( P=0.03 ) . There was no difference in the amount of morphine equivalents used between groups postoperatively . Flatus and first bowel movement returned a median of 3 and 4 days , respectively , after conventional roscopicvs . 3.3 and 4 days , respectively , after conventional surgery ( P=0.21 ) . Median length of stay was five ( range , 4–30 ) days for laparoscopic , and six ( range , 4–18 ) days for conventional surgery . Major complications occurred in one patient in each group . Minor complications occurred in four laparoscopic and eight conventional patients ( P<0.05 ) . There were no deaths . Two laparoscopic patients were converted to conventional as a result of adhesions or inflammation . All patients recovered well and there were no clinical resurrences in the follow-up period ( median , 20 ; range , 12–45 months ) . CONCLUSIONS : Within a single insititution , single surgical team , prospect i ve , r and omized trial , laparoscopic techniques offered a faster recovery of pulomary function , fewer complications , and shorter length of stay compared with conventional surgery for selected patients undergoing ileocolic resection for Crohn 's disease UNLABELLED We compared the effects of a laparoscopic ( n = 23 ) versus laparotomic ( n = 21 ) technique for major abdominal surgery on temperature control in 44 patients undergoing colorectal surgery during a combined epidural/general anesthesia . A thoracic epidural block up Output:	Operative time was longer in laparoscopic surgery , but intraoperative blood was less than in conventional surgery . Intensity of postoperative pain and duration of postoperative ileus was shorter after laparoscopic colorectal resection and pulmonary function was improved after a laparoscopic approach . Total morbidity and local ( surgical ) morbidity was decreased in the laparoscopic groups . General morbidity and mortality was not different between both groups . Until the 30th postoperative day , quality of life was better in laparoscopic patients . Postoperative hospital stay was less in laparoscopic patients . Under traditional perioperative treatment , laparoscopic colonic resections show clinical ly relevant advantages in selected patients .
MS2640	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The natural history of allergic sensitization is complex and poorly understood . A prospect i ve nonr and omized study was carried out in a population of asthmatic children younger than 6 years of age whose only allergic sensitivity was to house dust mites ( HDMs ) . OBJECTIVES The study was design ed to determine whether specific immunotherapy ( SIT ) with st and ardized allergen extracts could prevent the development of new sensitizations over a 3-year follow-up survey . METHODS We studied 22 children monosensitized to HDM who were receiving SIT with st and ardized allergen extracts and 22 other age-matched control subjects who were monosensitized to HDM . The initial investigation included a full clinical history , skin tests with a panel of st and ardized allergens , and the measurement of allergen-specific IgE , depending on the results of skin tests . Children were followed up on an annual basis for 3 years , and the development of new sensitizations in each group was recorded . RESULTS Ten of 22 children monosensitized to HDM who were receiving SIT did not have new sensitivities compared with zero of 22 children in the control group ( p = 0.001 , chi square test ) . CONCLUSIONS This study suggests that SIT in children monosensitized to HDM alters the natural course of allergy in preventing the development of new sensitizations Background : Although widely practice d for over 80 years , the role of specific immunotherapy ( SIT ) in pediatric asthma treatment is still controversial . We assessed the effects of a 3‐year period of subcutaneous administration of a st and ardized preparation of Dermatophagoides pteronyssinus ( D pt ) on the respiratory health in a group of asthmatic children monosensitized to house dust mite ( HDM ) BACKGROUND Previous studies have suggested that single-allergen-specific immunotherapy ( SIT ) may prevent sensitization to other airborne allergens in monosensitized children . We aim ed to assess the prevention of new sensitizations in monosensitized children treated with single-allergen SIT injections in comparison with monosensitized patients given appropriate pharmacologic treatment for their disease . METHODS A total of 147 children with rhinitis and /or asthma monosensitized to house dust mite were studied ; 45 patients underwent SIT with adsorbed extracts and 40 patients underwent SIT with aqueous extracts for 5 years . The control group was comprised of 62 patients given only pharmacologic treatment for at least 5 years . Skin prick tests , medication scores for rhinitis and asthma , and atopy scores according to skin prick tests were evaluated at the beginning and after 5 years of treatment . RESULTS All groups were comparable in terms of age , sex , and disease characteristics . At the end of 5 years , 64 out of 85 ( 75.3 % ) in the SIT group showed no new sensitization , compared to 29 out of 62 children ( 46.7 % ) in the control group ( P = .002 ) . There were no differences between the SIT subgroups with regard to onset of new sensitization ( P = .605 ) . The patients developing new sensitizations had higher atopy scores ( P = .002 ) and medication scores for both rhinitis ( P = .008 ) and asthma ( P = .013 ) in comparison to patients not developing new sensitizations after 5 years of SIT . CONCLUSION According to our data , SIT has the potential to prevent the onset of new sensitizations in children with rhinitis and /or asthma monosensitized to house dust mite BACKGROUND Sublingual immunotherapy ( SLIT ) has been proved to be effective in allergic rhinitis and asthma , but there are few data on its preventive effects , especially in children . OBJECTIVE To evaluate the clinical and preventive effects of SLIT in children by assessing onset of persistent asthma and new sensitizations , clinical symptoms , and bronchial hyperreactivity . METHODS A total of 216 children with allergic rhinitis , with or without intermittent asthma , were evaluated and then r and omized to receive drugs alone or drugs plus SLIT openly for 3 years . The clinical score was assessed yearly during allergen exposure . Pulmonary function testing , methacholine challenge , and skin prick testing were performed at the beginning and end of the study . RESULTS One hundred forty-four children received SLIT and 72 received drugs only . Dropouts were 9.7 % in the SLIT group and 8.3 % in the controls . New sensitizations appeared in 34.8 % of controls and in 3.1 % of SLIT patients ( odds ratio , 16.85 ; 95 % confidence interval , 5.73 - 49.13 ) . Mild persistent asthma was less frequent in SLIT patients ( odds ratio , 0.04 ; 95 % confidence interval , 0.01 - 0.17 ) . There was a significant decrease in clinical scores in the SLIT group vs the control group since the first year . The number of children with a positive methacholine challenge result decreased significantly after 3 years only in the SLIT group . Adherence was 80 % or higher in 73.8 % of patients . Only 1 patient reported systemic itching . CONCLUSIONS In everyday clinical practice , SLIT reduced the onset of new sensitizations and mild persistent asthma and decreased bronchial hyperreactivity in children with respiratory allergy BACKGROUND Allergic rhinitis ( AR ) is a main risk factor for the development of asthma . Two r and omized open-label trials indicated that allergy immunotherapy ( AIT ) prevents the onset of asthma in patients with AR . However , these trials have method ological limitations , and it is unclear to what extent this experimental efficacy translates into clinical effectiveness . OBJECTIVES We sought to investigate the effectiveness of AIT to prevent asthma in patients with AR . METHODS Using routine health care data from German National Health Insurance beneficiaries , we identified a consecutive cohort of 118,754 patients with AR but without asthma who had not received AIT in 2005 . These patients were stratified into one group starting AIT in 2006 and one group receiving no AIT in 2006 . Both groups were observed regarding the risk of incident asthma in 2007 to 2012 . Risk ratios ( RRs ) were calculated with generalized linear models by using a Poisson link function with robust error variance and adjustment for age , sex , health care use because of AR , and use of antihistamines . RESULTS In a total of 2431 ( 2.0 % ) patients , AIT was started in 2006 . Asthma was newly diagnosed from 2007 - 2012 in 1646 ( 1.4 % ) patients . The risk of incident asthma was significantly lower in patients exposed to AIT ( RR , 0.60 ; 95 % CI , 0.42 - 0.84 ) compared with patients receiving no AIT in 2006 . Sensitivity analyses suggested significant preventive effects of subcutaneous immunotherapy ( RR , 0.54 ; 95 % CI , 0.38 - 0.84 ) and AIT including native ( nonallergoid ) allergens ( RR , 0.22 ; 95 % CI , 0.02 - 0.68 ) . AIT for 3 or more years tended to have stronger preventive effects than AIT for less than 3 years . CONCLUSION AIT effectively prevents asthma in patients with AR in a real-world setting . Confounding by indication can not be excluded but would lead to an underestimation of the true preventive effects of AIT BACKGROUND We wondered whether short-term coseasonal sublingual immunotherapy ( SLIT ) can reduce the development of asthma in children with hay fever in an open r and omized study . OBJECTIVE We sought to determine whether SLIT is as effective as subcutaneous immunotherapy in reducing hay fever symptoms and the development of asthma in children with hay fever . METHODS One hundred thirteen children aged 5 to 14 years ( mean age , 7.7 years ) with hay fever limited to grass pollen and no other clinical ly important allergies were r and omized in an open study involving 6 Italian pediatric allergy centers to receive specific SLIT for 3 years or st and ard symptomatic therapy . All of the subjects had hay fever symptoms , but at the time of study entry , none reported seasonal asthma with more than 3 episodes per season . Symptomatic treatment was limited to cetirizine , loratadine , nasal budesonide , and salbutamol on dem and . The hay fever and asthma symptoms were quantified clinical ly . RESULTS The actively treated children used less medication in the second and third years of therapy , and their symptom scores tended to be lower . From the second year of immunotherapy , subjective evaluation of overall allergy symptoms was favorable in the actively treated children . Development of asthma after 3 years was 3.8 times more frequent ( 95 % confidence limits , 1.5 - 10.0 ) in the control subjects . CONCLUSIONS Three years of coseasonal SLIT improves seasonal allergic rhinitis symptoms and reduces the development of seasonal asthma in children with hay fever BACKGROUND Allergen specific immunotherapy is the only specific and curative approach in the treatment of IgE-mediated allergic diseases such as bronchial asthma and allergic rhinitis . The safety and clinical efficacy of this treatment are well documented but data on the prevention of new sensitizations remain scarce . OBJECTIVE To demonstrate the efficacy of specific immunotherapy in allergic respiratory diseases in childhood and to determine whether this treatment prevents the development of new sensitizations in children sensitized to house dust mite or pollen species . METHODS Fifty-six patients received specific immunotherapy ( 43 sensitive to house dust mite and 13 sensitive to pollen ) . Fifty-one patients not receiving immunotherapy but treated with pharmacotherapy were enrolled in the control group . The patients were followed-up for at least 4 years and treatment efficacy and the development of new sensitizations were compared between the two groups . RESULTS The number of patients with symptoms was significantly decreased in both groups at the end of the treatment period . No new sensitizations were found in 35 of the 43 ( 81.39 % ) patients in the house dust mite immunotherapy group and in 10 of 13 ( 76.92 % ) patients in the pollen immunotherapy group . In contrast , 20 of 51 ( 39.21 % ) patients in the control group showed new sensitizations . The difference between the house dust mite and pollen immunotherapy groups and the control group in this parameter was statistically significant ( p = 0.033 ) . CONCLUSION Our data demonstrate that administration of specific immunotherapy in allergic patients significantly reduced symptoms and the development of new sensitivities BACKGROUND Children with allergic rhinitis are likely to develop asthma . OBJECTIVE The purpose of this investigation was to determine whether specific immunotherapy can prevent the development of asthma and reduce bronchial hyperresponsiveness in children with seasonal allergic rhinoconjunctivitis . METHODS From 6 pediatric allergy centers , 205 children aged 6 to 14 years ( mean age , 10.7 years ) with grass and /or birch pollen allergy but without any other clinical ly important allergy were r and omized either to receive specific immunotherapy for 3 years or to an open control group . All subjects had moderate to severe hay fever symptoms , but at inclusion none reported asthma with need of daily treatment . Symptomatic treatment was limited to loratadine , levocabastine , sodium cromoglycate , and nasal budesonide . Asthma was evaluated clinical ly and by peak flow . Methacholine bronchial provocation tests were carried out during the season(s ) and during the winter . RESULTS Before the start of immunotherapy , 20 % of the children had mild asthma symptoms during the pollen season(s ) . Among those without asthma , the actively treated children had significantly fewer asthma symptoms after 3 years as evaluated by clinical diagnosis ( odds ratio , 2.52 ; P < .05 ) . Methacholine bronchial provocation test results improved significant in the active group ( P < .05 ) . CONCLUSION Immunotherapy can reduce the development of asthma in children with seasonal rhinoconjunctivitis Background : Limited data exist regarding extended , long-term immunologic effects of immunotherapy in polysensitized individuals . To study possible long-term effects , skin tests and specific IgE levels were obtained from subjects who had previously received broad-spectrum aeroallergen immunotherapy years before . Methods : Eighty-two subjects ( 78 % male , mean age 23 years ) previously enrolled in a r and omized , placebo-controlled trial of immunotherapy for treatment of childhood allergic asthma were reevaluated in adulthood ( mean follow-up interval , 10.8 years ) by puncture skin tests and CAP-RAST levels for major aeroallergens . All completed at least 18 months ( median 27 months ) of maintenance active treatment or placebo injections without subsequent immunotherapy . Results : At adult follow-up , 36 % of all skin tests to treatment allergens among subjects who received immunotherapy ( n = 41 ) had significantly reduced intensity versus 26 % of skin tests among placebo recipients ( n = 41 ; p = 0.03 ) . No significant differences were noted for individual treatment allergens . No significant differences were observed in the long-term changes of serum-specific IgE antibody levels for all treatment allergens between immun Output:	AIT appeared to have an acceptable side effect profile . CONCLUSIONS AIT did not result in a statistically significant reduction in the risk of developing a first allergic disease . There was , however , evidence of a reduced short-term risk of developing asthma in those with allergic rhinitis , but it is unclear whether this benefit was maintained over the longer term . We are unable to comment on the cost-effectiveness of AIT
MS2641	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: UNLABELLED Recent animal studies demonstrate that compulsive cocaine seeking strongly reduces prelimbic frontal cortex activity , while optogenetic stimulation of this brain area significantly inhibits compulsive cocaine seeking , providing a strong rationale for applying brain stimulation to reduce cocaine consumption . Thus , we employed repetitive transcranial magnetic stimulation ( rTMS ) , to test if dorsolateral prefrontal cortex ( DLPFC ) stimulation might prevent cocaine use in humans . Thirty-two cocaine-addicted patients were r and omly assigned to either the experimental group ( rTMS ) on the left DLPFC , or to a control group ( pharmacological agents ) during a 29-day study ( Stage 1 ) . This was followed by a 63-day follow-up ( Stage 2 ) , during which all participants were offered rTMS treatment . Amongst the patients who completed Stage 1 , 16 were in the rTMS group ( 100 % ) and 13 in the control group ( 81 % ) . No significant adverse events were noted . During Stage 1 , there were a significantly higher number of cocaine-free urine drug tests in the rTMS group compared to control ( p=0.004 ) . Craving for cocaine was also significantly lower in the rTMS group compared to the controls ( p=0.038 ) . Out of 13 patients who completed Stage 1 in the control group , 10 patients received rTMS treatment during Stage 2 and showed significant improvement with favorable outcomes becoming comparable to those of the rTMS group . The present preliminary findings support the safety of rTMS in cocaine-addicted patients , and suggest its potential therapeutic role for rTMS-driven PFC stimulation in reducing cocaine use , providing a strong rationale for developing larger placebo-controlled studies . Trial name : Repetitive transcranial magnetic stimulation ( rTMS ) in cocaine abusers , URL : 〈http://www.is rct n.com/IS RCT N15823943?q=&filters=&sort=&offset=8&total Results = 13530&page=1&pageSize=10 & search Type = basic- search 〉 , REGISTRATION NUMBER IS RCT N15823943 BACKGROUND Tobacco smoking is the leading cause of preventable death in developed countries . Our previous studies in animal models and humans suggest that repeated activation of cue-induced craving networks followed by electromagnetic stimulation of the dorsal prefrontal cortex ( PFC ) can cause lasting reductions in drug craving and consumption . We hypothesized that disruption of these circuitries by deep transcranial magnetic stimulation ( TMS ) of the PFC and insula bilaterally can induce smoking cessation . METHODS Adults ( N = 115 ) who smoke at least 20 cigarettes/day and failed previous treatments were recruited from the general population . Participants were r and omized to receive 13 daily sessions of high-frequency , low-frequency or sham stimulation following , or without , presentation of smoking cues . Deep TMS was administered using an H-coil version targeting the lateral PFC and insula bilaterally . Cigarette consumption was evaluated during the treatment by measuring cotinine levels in urine sample s and recording participants ' self-reports as a primary outcome variable . Dependence and craving were assessed using st and ardized question naires . RESULTS High ( but not low ) frequency deep TMS treatment significantly reduced cigarette consumption and nicotine dependence . The combination of this treatment with exposure to smoking cues enhanced reduction in cigarette consumption leading to an abstinence rate of 44 % at the end of the treatment and an estimated 33 % 6 months following the treatment . CONCLUSIONS This study further implicates the lateral PFC and insula in nicotine addiction and suggests the use of deep high-frequency TMS of these regions following presentation of smoking cues as a promising treatment strategy AIMS As alcohol dependency is characterized by severe executive function deficits , we examined the influence of high-frequency ( HF ) repetitive transcranial magnetic stimulation ( rTMS ) applied to the right dorsolateral prefrontal cortex ( DLPFC ) on executive functioning in recently detoxified alcohol-dependent patients . METHODS In this r and omized , single blind , sham (placebo)-controlled , crossover study , we included 50 detoxified alcohol-dependent patients . We examined the effect of a single right DLPFC HF-rTMS session on commission errors , mean reaction times ( RTs ) and intra-individual reaction time variability ( IIRTV ) during a Go-NoGo task ( 50 % Go/50 % NoGo condition ) in 29 alcohol-dependent patients . Patients completed this cognitive task immediately before and immediately after the stimulation session . In order to avoid carry-over effects between stimulation sessions , a 1-week inter-session interval was respected . Because rTMS treatment has been shown to affect subjective craving , all patients were also assessed with the Obsessive Compulsive Drinking Scale ( OCDS ) . RESULTS After both stimulation conditions , we observed a significant decrease of commission errors , without differences between active and sham HF-rTMS stimulation . No significant difference was observed between active and sham stimulation on mean RT . However , only active stimulation result ed in a significant decrease in IIRTV . No effects of stimulation were found for the craving measurements . CONCLUSION Our findings suggest that in recently detoxified alcohol-dependent patients , one right-sided HF-rTMS session stabilizes cognitive performance during executive control tasks , implying that active stimulation reduces patients ' proneness to attentional lapses Drug-related cues induce craving , which may perpetuate drug use or trigger relapse in addicted individuals . Craving is also under the influence of other factors in daily life , such as drug availability and self-control . Neuroimaging studies using drug cue paradigms have shown frontal lobe involvement in this context ual influence on cue reactivity , but have not clarified how and which frontal area accounts for this phenomenon . We explored frontal lobe contributions to cue-induced drug craving under different intertemporal drug availability conditions by combining transcranial magnetic stimulation and functional magnetic resonance imaging in smokers . We hypothesized that the dorsolateral prefrontal cortex ( DLPFC ) regulates craving during changes in intertemporal availability . Subjective craving was greater when cigarettes were immediately available , and this effect was eliminated by transiently inactivating the DLPFC with transcranial magnetic stimulation . Functional magnetic resonance imaging demonstrated that the signal most proportional to subjective craving was located in the medial orbitofrontal cortex across all context s , whereas the DLPFC most strongly encoded intertemporal availability information . The craving-related signal in the medial orbitofrontal cortex was attenuated by inactivation of the DLPFC , particularly when cigarettes were immediately available . Inactivation of the DLPFC also reduced craving-related signals in the anterior cingulate and ventral striatum , areas implicated in transforming value signals into action . These findings indicate that DLPFC builds up value signals based on knowledge of drug availability , and support a model wherein aberrant circuitry linking dorsolateral prefrontal and orbitofrontal cortices may underlie addiction BACKGROUND Addiction is associated with dorso-lateral prefrontal cortex ( DLPFC ) dysfunction and altered brain-oscillations . High frequency repetitive transcranial magnetic stimulation ( HFrTMS ) over DLPFC reportedly reduces drug craving . Its effects on neuropsychological , behavioural and neurophysiological are unclear . METHODS We assessed psychological , behavioural and neurophysiological effects of 4 sessions of 10-min adjunctive HFrTMS over the left DLPFC during two weeks during a residential programme for alcohol detoxification . Participants were r and omized to active HFrTMS ( 10 Hz , 100 % motor threshold ) or sham . Immediately before the first and after the last session , 32-channels EEG was recorded and alcohol craving Visual Analogue Scale , Symptom Check List-90-R , Numeric Stroop task and Go/No-go task administered . Tests were repeated at 1-month follow-up . RESULTS 17 subjects ( mean age 44.7 years , 4 F ) were assessed . Active rTMS subjects performed better at Stroop test at end of treatment ( p=0.036 ) and follow up ( p=0.004 ) and at Go-NoGo at end of treatment ( p=0.05 ) and follow up ( p=0.015 ) . Depressive symptoms decreased at end of active treatment ( p=0.036 ) . Active-TMS showed an overall decrease of fast EEG frequencies after treatment compared to sham ( p=0.026 ) . No significant modifications over time or group emerged for craving and number of drinks at follow up . CONCLUSION 4 HFrTMS sessions over two weeks on the left DLPFC can improve inhibitory control task and selective attention and reduce depressive symptoms . An overall reduction of faster EEG frequencies was observed . Nonetheless , this schedule is ineffective in reducing craving and alcohol intake BACKGROUND Prior research in substance dependence has suggested potential anti-craving effects of repetitive transcranial magnetic stimulation ( rTMS ) when applied to the dorsolateral prefrontal cortex ( DLPFC ) . However , no single sham-controlled session studies applied to the right DLPFC have been carried-out in recently detoxified alcohol-dependent patients . Furthermore , no studies examined the effect of a single HF-rTMS session on craving in these patients ' natural habitat . METHODS To further investigate the effect of high-frequency (HF)-rTMS of the right DLPFC on alcohol craving , we performed a prospect i ve , single-blind , sham-controlled study involving 36 hospitalized patients with alcohol dependence syndrome . After successful detoxification , patients were allocated receiving one active or one sham HF-rTMS session . The obsessive-compulsive drinking scale ( OCDS ) was administered to evaluate the extent of craving just before and after the HF-rTMS session ( on Friday ) , on Saturday and Sunday during the weekend at home , and on Monday when the patient returned to the hospital . RESULTS One single blind sham-controlled HF-rTMS session applied to the right DLPFC did not result in changes in craving ( neither immediately after the stimulation session , nor in patients ' natural environment during the weekend ) . CONCLUSIONS One HF-rTMS stimulation session applied to the right DLPFC had no significant effects on alcohol craving in alcohol dependent patients . One such session could have been too short to alter alcohol craving in a sample of alcohol dependent patients Dopamine is implicated in movement , learning , and motivation , and in illnesses such as Parkinson 's disease , schizophrenia , and drug addiction . Little is known about the control of dopamine release in humans , but research in experimental animals suggests that the prefrontal cortex plays an important role in regulating the release of dopamine in subcortical structures . Here we used [(11)C]raclopride and positron emission tomography to measure changes in extracellular dopamine concentration in vivo after repetitive transcranial magnetic stimulation ( rTMS ) of the dorsolateral prefrontal cortex in healthy human subjects . Repetitive TMS of the left dorsolateral prefrontal cortex caused a reduction in [(11)C]raclopride binding in the left dorsal cau date nucleus compared with rTMS of the left occipital cortex . There were no changes in binding in the putamen , nucleus accumbens , or right cau date . This shows that rTMS of the prefrontal cortex induces the release of endogenous dopamine in the ipsilateral cau date nucleus . This finding has implication s for the therapeutic and research use of rTMS in neurological and psychiatric disorders BACKGROUND Positron emission tomography ( PET ) imaging studies have shown that addiction to a number of substances of abuse is associated with a decrease in dopamine D(2/3 ) receptor binding and decreased presynaptic dopamine release in the striatum . Some studies have also shown that these reductions are associated with the severity of addiction . For example , in cocaine dependence , low dopamine release is associated with the choice to self-administer cocaine . The goal of the present study was to investigate these parameters of striatal dopamine transmission in heroin dependence and their association with drug seeking behavior . METHODS Heroin-dependent and healthy control subjects were scanned with [(11)C]raclopride before and after stimulant administration ( methylpheni date ) to measure striatal D(2/3 ) receptor binding and presynaptic dopamine release . After the PET scans , the heroin-dependent subjects performed heroin self-administration sessions . RESULTS Both striatal D(2/3 ) receptor binding and dopamine release were reduced in the heroin-dependent subjects compared with healthy control subjects . However , neither PET measure of dopamine transmission predicted the choice to self-administer heroin . CONCLUSIONS These findings show that heroin addiction , like addiction to other drugs of abuse , is associated with low D(2/3 ) receptor binding and low presynaptic dopamine . However , neither of these outcome measures was associated with the choice to self-administer heroin We used PET (15)O and a modified version of the Stroop task to determine if 25-day abstinent heavy marijuana ( MJ ) users have persistent deficits in executive cognitive functioning ( ECF ) and brain activity . Performance on a modified version of the Stroop task and brain activity was compared between 25-day abstinent , heavy marijuana users ( n = 11 ) , and a matched comparison group ( n = 11 ) . The 25-day abstinent marijuana users showed no deficits in performance on the modified version of the Stroop task when compared to the comparison group . Despite the lack of performance differences , the marijuana users showed hypoactivity in the Output:	Effects of other rTMS protocol s on craving were not significant . However , when examining substance consumption , excitatory rTMS of the left DLPFC and excitatory deep TMS ( dTMS ) of the bilateral DLPFC and insula revealed significant consumption-reducing effects , compared with sham stimulation . Excitatory repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex appears to have an acute effect on reducing craving and substance consumption in patients with substance dependence . The anti-craving effect may be associated with stimulation dose
MS2642	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Direct-acting antiviral ( DAA ) therapy for hepatitis C virus ( HCV ) infection has result ed in high rates of disease cure ; however , not enough specialists currently are available to provide care . Objective To determine the efficacy of HCV treatment independently provided by nurse practitioners ( NPs ) , primary care physicians ( PCPs ) , or specialist physicians using DAA therapy . Design Nonr and omized , open-label clinical trial initiated in 2015 . ( Clinical Trials.gov : NCT02339038 ) . Setting 13 urban , federally qualified health centers ( FQHCs ) in the District of Columbia . Patients A referred sample of 600 patients , of whom 96 % were black , 69 % were male , 82 % were treatment naive , and 20 % had cirrhosis . Seventy-two percent of the patients had HCV genotype 1a infection . The baseline characteristics of patients seen by each provider type were similar . Intervention Patients were assigned in a nonr and omized but specified manner to receive treatment from 1 of 5 NPs , 5 PCPs , or 6 specialists . All providers underwent an identical 3-hour training session based on guidelines . Patients received treatment with ledipasvir-sofosbuvir , which was provided on site , according to U.S. Food and Drug Administration labeling requirements . Measurements Sustained virologic response ( SVR ) . Results 516 patients achieved SVR , a response rate of 86 % ( 95 % CI , 83.0 % to 88.7 % ) , with no major safety signals . Response rates were consistent across the 3 provider types : NPs , 89.3 % ( CI , 83.3 % to 93.8 % ) ; PCPs , 86.9 % ( CI , 80.6 % to 91.7 % ) ; and specialists , 83.8 % ( CI , 79.0 % to 87.8 % ) . Patient loss to follow-up was the major cause of non-SVR . Limitation Nonr and omized patient distribution ; possible referral bias . Conclusion In a real-world cohort of patients at urban FQHCs , HCV treatment administered by nonspecialist providers was as safe and effective as that provided by specialists . Nurse practitioners and PCPs with compact didactic training could substantially exp and the availability of community-based providers to escalate HCV therapy , bridging existing gaps in the continuum of care for patients with HCV infection . Primary Funding Source National Institutes of Health and Gilead Sciences BACKGROUND Direct-acting antiviral therapy ( DAAs ) for hepatitis C infection ( HCV ) have a much smaller burden of treatment than interferon-based regimes , require less monitoring and are very effective . New pathways are required to increase access to treatment amongst people prescribed opioid substitution therapy ( OST ) . METHODS An exploratory cluster r and omised controlled trial with mixed methods evaluation was undertaken to compare the uptake of dried blood spot testing ( DBST ) and treatment of people with genotype 1 HCV infection in a conventional service pathway versus a pharmacist-led pathway in a population receiving OST . RESULTS Pharmacies r and omised to the conventional pathway obtained 58 DBST from 244 patients (24%):15 new reactive tests and 33 new negative tests were identified . Within the pharmacist-led pathway , 94 DBST were obtained from 262 patients ( 36 % ) : 26 new reactive tests and 54 new negative tests were identified . Participants in the pharmacist-led pathway were more likely to take a DBST ( p<0.003 ) . Of participants referred for treatment through the conventional pathway , 4 patients from 15 with new reactive tests ( 27 % ) attended clinic for assessment . In the pharmacist-led treatment pathway , 20 patients from 26 with new reactive tests ( 77 % ) attended for assessment blood tests . Participants in the pharmacist-led pathway were more likely to proceed through the assessment for treatment ( p<0.002 ) . One participant completed treatment through the conventional pathway and three patients completed treatment through the pharmacist-led pathway . The process evaluation identified key themes important to service user completers and staff participants . CONCLUSION The study provides evidence that testing and treatment for HCV in a pharmacist led-pathway is a feasible treatment pathway for people who receive supervised OST consumption through community pharmacies . This feasibility trial therefore provides sufficient confirmation to justify proceeding to a full trial OBJECTIVES To revise 2010 guidance on grading the strength of evidence ( SOE ) of the effectiveness of drugs , devices , and other preventive and therapeutic interventions in systematic review s produced by the Evidence -based Practice Center ( EPC ) program , established by the US Agency for Healthcare Research and Quality ( AHRQ ) . STUDY DESIGN AND SETTING A cross-EPC working group review ed authoritative systems for grading SOE [ primarily the approach from the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) working group ] and conducted extensive discussion s with GRADE and other experts . RESULTS Up date d guidance continues to be conceptually similar to GRADE . Review ers are to evaluate SOE separately for each major treatment comparison for each major outcome . We added reporting bias as a required domain and retained study limitations ( risk of bias ) , consistency , directness , and precision ( and three optional domains ) . Additional guidance covers scoring consistency , precision , and reporting bias , grading bodies of evidence with r and omized controlled trials and observational studies , evaluating single study bodies of evidence , using studies with high risk of bias , and presenting findings with greater clarity and transparency . SOE is grade d high , moderate , low , or insufficient , reflecting review ers ' confidence in the findings for a specific treatment comparison and outcome . CONCLUSION No single approach for grading SOE suits all review s , but a more consistent and transparent approach to reporting summary information will make review s more useful to the broad range of audiences that AHRQ 's work aims to reach . EPC working groups will consider ongoing challenges and modify guidance as needed , on issues such as combining trials and observational studies in bodies of evidence , weighting domains , and combining qualitative and quantitative syntheses BACKGROUND Though direct acting antivirals ( DAAs ) promise high cure rates , many providers and payers remain concerned about successful treatment for people who use drugs ( PWUD ) , even among those engaged in opioid agonist treatment ( OAT ) . The efficacy of DAAs among PWUD in real-world setting s is unclear . METHODS We conducted a cohort study of patients initiating HCV treatment between January 2014 and August 2015 ( n=89 ) at a primary care clinic in the Bronx , NY . Onsite HCV treatment with DAAs was performed by an HCV specialist , with support from a care coordinator funded by the NYC Department of Health . We identified four categories of drug use and drug treatment : ( 1 ) no active drug use/not receiving OAT ( defined as non-PWUD ) ; ( 2 ) no active drug use/receiving OAT ; ( 3 ) active drug use/not receiving OAT ; and ( 4 ) active drug use/receiving OAT . The primary outcome was SVR at 12 weeks post-treatment . RESULTS Overall SVR rates were 95 % ( n=41/43 ) for non-PWUD and 96 % ( n=44/46 ) for patients actively using drugs and /or receiving OAT [ p=0.95 ] . There were no differences in SVR rates by drug use or drug treatment category . Compared to non-PWUD , those with no active drug use/receiving OAT had 100 % SVR ( n=15/15 ; p=1.0 ) , those actively using drugs/not receiving OAT had 90 % SVR ( n=9/10 ; p=0.47 ) , and those actively using drugs/receiving OAT had 95 % SVR ( 20/21 ; p=1.0 ) . CONCLUSION Regardless of active drug use or OAT , patients who received DAA therapy at an urban primary care clinic achieved high HCV cure rates . We found no clinical evidence to justify restricting access to HCV treatment for patients actively using drugs and /or receiving OAT Introduction Hepatitis C virus ( HCV ) infection affects 0.7 % of the general population , and up to 40 % of people prescribed opioid substitution therapy ( OST ) in Scotl and . In conventional care , less than 10 % of OST users are tested for HCV and less than 25 % of these initiate treatment . Community pharmacists see this group frequently to provide OST supervision . This study examines whether a pharmacist-led ‘ test & treat ’ pathway increases cure rates for HCV . Methods and analysis This protocol describes a cluster-r and omised trial where 60 community pharmacies provide either conventional or pharmacy-led care . All pharmacies offer dried blood spot testing ( DBST ) for HCV . Participants have attended the pharmacy for OST for 3 months ; are positive for HCV genotype 1 or 3 ; are not co-infected with HIV and /or hepatitis B ; have no decompensated liver disease ; are not pregnant . For conventional care , pharmacists refer HCV-positive participants to a local centre for assessment . In the pharmacy-led arm , pharmacists assess participants themselves in the pharmacy . Drug prescribing is by nurse prescribers ( conventional arm ) or pharmacist prescribers ( pharmacy-led arm ) . Treatment in both arms is delivered as daily modified directly observed therapy in a pharmacy . Primary trial outcome is number of sustained virological responses at 12 weeks after treatment completion . Secondary trial outcomes are number of tests taken ; treatment uptake ; completion ; adherence ; re-infection . An economic evaluation will assess potential cost-effectiveness . Qualitative research interviews with clients and health professionals assess acceptability of a pharmacist-led pathway . Ethics and dissemination This protocol has been ethically approved by the East of Scotl and Research Ethics Committee 2 ( 15/ES/0086 ) and complies with the Declaration of Helsinki and principles of Good Clinical Practice . Caldicott guardian approval was given on 16 December 2016 to allow NHS Tayside to pass information to the cluster community pharmacies about the HCV test status of patients that they are seeing to provide OST supervision . NHS R&D approvals have been obtained from each health board taking part in the study . Informed consent is obtained before study enrolment and only anonymised data are stored in a secured data base , enabling an audit trail . Results will be su bmi tted to international peer- review ed journals and presented at international conferences . Trial registration number NCT02706223 ; Pre- results BACKGROUND To achieve the World Health Organization hepatitis C elimination targets , it is essential to increase access to direct acting antivirals ( DAAs ) - especially amongst people who inject drugs ( PWID ) . We aim ed to determine the effectiveness of providing DAAs in primary care compared with hospital-based specialist care . METHODS We r and omised PWID with hepatitis C attending primary care sites in Australia or New Zeal and to receive DAAs at their primary care site or local hospital ( st and ard of care ( SOC ) ) . The primary outcome was to determine if people treated in primary care had a non-inferior sustained virologic response at week 12 ( SVR12 ) rate compared to historical controls ( consistent with DAA trials at the time of study design ) ; secondary outcomes included comparison of treatment initiation , SVR12 rates , and the care cascade by study arm . RESULTS We recruited 140 participants and r and omised 136 ; 70 to primary care and 66 to SOC . The SVR12 rate ( 100 % , 95 % CI , 87.7 - 100 ) of people treated in primary care was non-inferior when compared to historical controls ( 85 % assumed ) . Intention to treat analysis revealed that the proportion of participants commencing treatment in primary care ( 75 % , 43/57 ) was significantly higher than in SOC ( 34 % , 18/53 ) ( p<0.001 ; RR 2.48 ; 95 % CI , 1.54 - 3.95 ) , and the proportion of participants with SVR12 was significantly higher in primary care compared to SOC ( 49 % , 28/57 and 30 % , 16/53 ) ( p=0.043 ; RR 1.63 ; 95 % CI,1.0 - 2.65 ) . CONCLUSION Providing hepatitis C treatment in primary care increases treatment uptake and cure . Approaches that increase treatment uptake amongst PWID will accelerate elimination strategies Output:	ConclusionS ervices sited in community setting s are feasible and can deliver increased uptake of treatment . Such clinics are able to demonstrate similar SVR rates to published studies and real-world clinics in secondary care .
MS2643	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Latino family caregivers of older people with memory problems are a rapidly growing group . However , their participation in intervention research is disproportionately low . The authors compared the participant retention rates of three different recruitment strategies in a sample of Latino and Caucasian family caregivers . METHODS A total of 310 caregivers ( 195 Latino and 105 Caucasian ) were screened for participation in one of two clinical intervention trials . Potential participants were recruited from one of three sources : 1 ) non-professional ( e.g. , health fairs ) ; 2 ) professional ( e.g. , community agencies ) ; and 3 ) advertisements . Reasons for non-participation were also obtained . RESULTS Caucasians were significantly more likely to be successfully retained across all recruitment strategies ( 52 % versus 31 % , respectively ) . However , logistic regression revealed a recruitment strategy -by-ethnicity interaction : Latinos were highly similar in retention rates to Caucasians when recruited through professional referrals , and far less likely to participate with other strategies . Descriptive analyses also revealed ethnic differences for non-participation . CONCLUSION Partnership of Latino family caregivers with community agencies may result in the highest recruitment rates among this group . Latino cultural values likely play a role in the success of these partnerships in participant recruitment PURPOSE This article review s the problems associated with recruiting older minorities into mental health research studies and proposes a consumer-centered model of research methodology that addresses the barriers to recruitment and retention in this population . DESIGN AND METHODS The authors discuss and compare the results of recruitment and retention interventions for two geriatric mental health studies , one that used traditional methods of recruitment and retention and another that used consumer-centered methods . RESULTS Although the consumer-centered methods result in better recruitment of older minorities in general ( chi(2 ) = 54.90 , p < .001 ) , it was not superior to the traditional method in recruiting older minorities ( chi(2 ) = 0.82 , ns ) . However , the consumer-centered approach yielded better retention of older minorities ( chi(2 ) = 6.20 , p < .05 ) than did the traditional method . Within both methods , recruitment through provider referral and face-to-face contact were the superior recruitment methods ( chi(2 ) = 6.78 , p < .05 ) . Having an experienced recruiter or a community recruiter result ed in greater agreement to participate than simply having an ethnically matched recruiter ( chi(2 ) = 36.00 , p < .001 ) . IMPLICATION S Although these data are observational , and rigorous research on the best methods for recruiting and retaining older minorities is still necessary , the results suggest that a consumer-centered model of research yields greater overall recruitment and retention rates than do traditional research methods The negative consequences of untreated depression on the health and well-being of women and their children are well-documented , underscoring the need to develop effective interventions to prevent the onset of major depression during the perinatal period . This article describes recruitment data from two r and omized controlled trials of preventive interventions for postpartum depression : one conducted with immigrant Latinas in Washington , DC , United States , and the other with women in Mexico City , Mexico . In both countries , pregnant women met a priori eligibility criteria and were r and omized into an 8-week theory-based group intervention . Two hundred and seventeen Latinas in the U.S. and 377 women born and raised in Mexico were enrolled in their respective countries . The recruitment rates ( i.e. , the number of participants who met eligibility criteria , consented , and r and omized into the study ) were 70 % in the U.S. and in Mexico . Issues and recommendations related to recruiting Hispanic women into preventive intervention trials for postpartum depression are discussed OBJECTIVE Ethnic minority patients often receive poorer quality care and have worse outcomes than white patients , yet practice -based approaches to reduce such disparities have not been identified . We determined whether practice -initiated quality improvement ( QI ) interventions for depressed primary care patients improve care across ethnic groups and reduce outcome disparities . STUDY SETTING The sample consists of 46 primary care practice s in 6 U.S. managed care organizations ; 181 clinicians ; 398 Latinos , 93 African Americans , and 778 white patients with probable depressive disorder . STUDY DEIGN : Matched practice s were r and omized to usual care or one of two QI programs that trained local experts to educate clinicians ; nurses to educate , assess , and follow-up with patients ; and psychotherapists to conduct Cognitive Behavioral Therapy . Patients and physicians selected treatments . Interventions featured modest accommodations for minority patients ( e.g. , translations , cultural training for clinicians ) . DATA EXTRACTION METHODS Multilevel logistic regression analyses assessed intervention effects within and among ethnic groups . PRINCIPAL FINDINGS At baseline , all ethnic groups Latino , African American , white ) had low to moderate rates of appropriate care and the interventions significantly improved appropriate care at six months ( by 8 - 20 percentage points ) within each ethnic group , with no significant difference in response by ethnic group . The interventions significantly decreased the likelihood that Latinos and African Americans would report probable depression at months 6 and 12 ; the white intervention sample did not differ from controls in reported probable depression at either follow-up . While the intervention significantly improved the rate of employment for whites and not for minorities , precision was low for comparing intervention response on this outcome . It is important to note that minorities remained less likely to have appropriate care and more likely to be depressed than white patients . CONCLUSIONS Implementation of quality improvement interventions that have modest accommodations for minority patients can improve quality of care for whites and underserved minorities alike , while minorities may be especially likely to benefit clinical ly . Further research needs to clarify whether employment benefits are limited to whites and if so , whether this represents a difference in opportunities . Quality improvement programs appear to improve quality of care without increasing disparities , and may offer an approach to reduce health disparities BACKGROUND Rates of self-harm appear high in South Asian young women in the United Kingdom ( UK ) although previous studies were mostly small . Data on treatment and outcomes for South Asians are lacking . This study compared rates of self-harm , socio-demographic and clinical characteristics , provision of services and risk of repetition by ethnicity . METHOD A prospect i ve cohort of adult self-harm attendees ( n = 7185 ) , aged 15 and over presenting to four emergency departments in the cities of Manchester and Salford , UK over a 4-year period . RESULTS The study included 299 South Asians . South Asian women aged 16 - 24 years were more likely to self-harm than Whites of the same age group ( 1010.9 vs. 754 per 100,000 ) . Across all age groups the rates of self-harm were lower in South Asian men compared to White men and to South Asian women . South Asian women were significantly more likely to report relationship problems within the family than White women ( 32 % vs. 19 % , P = < 0.001 ) . South Asians were less likely than Whites to report depressive symptoms and to be offered specialist mental health services ( Rate ratio = 0.75 ) , and more likely to be referred back to the GP ( Rate ratio = 1.83 ) . South Asians were less likely to attend with a repeat episode ( Rate ratio = 0.56 ) . CONCLUSIONS Young South Asian women are at high risk of self-harm , but their clinical risk appears to be lower in terms of the accepted context ual factors contributing to risk . Potentially useful service provision may include an interpersonal problem solving approach although to be effective , interventions would need to be acceptable to South Asian women and culturally appropriate Output:	The barriers that were identified are not all unique to participants from ethnic minorities , although the way in which they manifest themselves is often distinct in minority groups .
MS2644	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES /HYPOTHESIS The effect of the Pillar implant on mild sleep-disordered breathing ( SDB ) has been assessed in various studies . However , most of these were conducted among a non-Asian population at a single institution . Therefore , the aim of this study was to prospect ively evaluate the efficacy of the Pillar implant in Asian patients with simple snoring and mild obstructive sleep apnea ( OSA ) at multiple centers . STUDY DESIGN Multicenter prospect i ve clinical trials . METHODS This study included consecutive subjects with simple snoring or mild OSA . We examined subjective symptoms ( snoring intensity , frequency , witnessed apnea , and daytime sleepiness ) and objective snoring and respiratory parameters ( snoring duration [ proportion of sleep while snoring louder than 50 dB ] , snoring loudness , apnea-hypopnea index , respiratory disturbance index , minimum arterial oxygen saturation , and oxygen desaturation index ≥ 4 % ) at 3 to 6 months after surgery . Adverse events were also investigated . RESULTS Twenty-nine subjects with mild SDB completed the study . Whole group analysis found significant improvements in various subjective symptoms , but not in the objective snoring and respiratory parameters . A subgroup analysis of subjects with mild OSA ( n = 11 ) found significant alleviation in various subjective symptoms , apnea-hypopnea index , respiratory disturbance index , and oxygen desaturation index ≥ 4 % . No major complication related to surgery was observed , and most minor adverse effects were resolved without morbidity . CONCLUSIONS In selected Korean patients , the Pillar implant significantly improved not only subjective symptoms of mild SDB but also respiratory disturbances in mild OSA . LEVEL OF EVIDENCE 2b BACKGROUND Limited data have suggested that sleep-disordered breathing , a condition of repeated episodes of apnea and hypopnea during sleep , is prevalent among adults . Data from the Wisconsin Sleep Cohort Study , a longitudinal study of the natural history of cardiopulmonary disorders of sleep , were used to estimate the prevalence of undiagnosed sleep-disordered breathing among adults and address its importance to the public health . METHODS A r and om sample of 602 employed men and women 30 to 60 years old were studied by overnight polysomnography to determine the frequency of episodes of apnea and hypopnea per hour of sleep ( the apnea-hypopnea score ) . We measured the age- and sex-specific prevalence of sleep-disordered breathing in this group using three cutoff points for the apnea-hypopnea score ( > or = 5 , > or = 10 , and > or = 15 ) ; we used logistic regression to investigate risk factors . RESULTS The estimated prevalence of sleep-disordered breathing , defined as an apnea-hypopnea score of 5 or higher , was 9 percent for women and 24 percent for men . We estimated that 2 percent of women and 4 percent of men in the middle-aged work force meet the minimal diagnostic criteria for the sleep apnea syndrome ( an apnea-hypopnea score of 5 or higher and daytime hypersomnolence ) . Male sex and obesity were strongly associated with the presence of sleep-disordered breathing . Habitual snorers , both men and women , tended to have a higher prevalence of apnea-hypopnea scores of 15 or higher . CONCLUSIONS The prevalence of undiagnosed sleep-disordered breathing is high among men and is much higher than previously suspected among women . Undiagnosed sleep-disordered breathing is associated with daytime hypersomnolence OBJECTIVE We sought to find a combination of noninvasive treatments for snoring by adding weight loss to previously studied treatments , including the combination of sleeping on one 's side and using a decongestant nasal spray . STUDY POPULATION Twenty asymptomatic men who snore heavily were studied previously on a control night and on a night when they slept on their side and used a nasal spray . With these two treatments , minor improvements in apnea/hypopnea index ( AHI ) were seen , but no improvement occurred in snoring frequency . Nineteen of these subjects subsequently completed a 6-month weight loss program , and 12 lost weight . These 19 subjects comprise the study population of this report . STUDY DESIGN At the conclusion of the weight loss program , a repeated sleep study was done from which the effect of adding weight loss to the two previously studied treatments could be assessed . RESULTS Those 12 subjects who lost any amount of weight showed a very mild reduction in snores per hour from 328 using two modalities of treatment to 232 per hour with the addition of weight loss ( p = 0.15 ) . The nine subjects who lost > or = 3 kg reduced the number of snores per hour from 320 to 176 ( p = 0.0496 ) . Three subjects losing an average of only 7.6 kg showed virtual elimination of snoring after weight loss . Subjects who gained weight had no improvement in snoring . Weight loss added to the other two modalities of treatment had no effect on the AHI . CONCLUSION In most cases , the combination of weight loss , sleeping on one 's side , and the administration of a nasal decongestant significantly reduces the frequency of snoring in asymptomatic men who snore heavily . The major effect appears to be related to weight loss OBJECTIVE The aim of this study was to assess the effects of laser irradiation with a novel snoring h and piece on the histological structures of the soft palate in a rat model . BACKGROUND Snoring is a common problem and studies have shown that 20 - 50 % of the population is affected . An apnea-hypopnea index of < 5/h without daytime somnolence is documented as simple snoring . No snoring treatment should ever be attempted until a sleep study has been completed to rule out sleep apnea . METHODS Twenty adult Wistar rats , weighing 200 - 250 g , were used in this study . Rats were r and omized into two groups : experimental group ( n = 10 ) and control group ( n = 10 ) . Laser energy was delivered in a horizontal direction to the surface of the soft palate of each rat in the experimental group for 2 min with an Er : YAG laser ( LightWalker AT ; Fotona ) with snoring h and piece ( PS04 ) in a noncontact mode ( 1.15 W , 2 Hz , 1.5 J/cm(2 ) ) . The animals were sacrificed after 24 h , 1 week , 3 weeks , or 5 weeks . The soft palate of each rat was removed by excisional biopsy . The specimens underwent histological examination . Contractions and fibrosis were reported as grading from 1 + to 3 + , while edema and hyperemia were evaluated according to the absence ( 0 ) or presence ( 1 ) of any changes . Statistical analysis was done with the Mann-Whitney U and Spearman 's rho tests . RESULT A noticeable contraction of the soft palate occurred immediately after laser application . Inflammatory changes were observed histologically at 3 weeks postoperatively . Keratinization appeared after the procedure in both groups and decreased gradually . Statistically , there was a strong correlation among inflammation and time and also keratinization and time ( p < 0.05 ) . CONCLUSIONS The present study indicates that Er : YAG laser irradiation with snoring h and piece ( PS04 ) causes acute shrinkage of the mucosa . This contraction decreases gradually but is still present at the end of fifth week Introduction : Adenotonsillar hypertrophy ( AH ) is considered the most common cause of upper respiratory tract obstruction among children . It results in a spectrum of symptoms from mouth breathing , nasal obstruction , hyponasal speech , snoring , and obstructive sleep apnea ( OSA ) to growth failure and cardiovascular morbidity . Adenotonsillectomy is a typical strategy for patients with AH , but may lead to serious complications such as bleeding ( 4–5 % ) and postoperative respiratory compromise ( 27 % ) , especially among young children , as well as recurrence of adenoid tissue ( 10–20 % ) . Thus , non-surgical therapies have attracted considerable attention as an alternative strategy . The inflammatory mechanism proposed for AH has lead to the use of anti-inflammatory drugs to manage this condition . The present study aim ed to evaluate the effect of chewable tablets of montelukast , a cysteinyl- leukotriene receptor antagonist , in children with AH . Material s and Methods : Sixty children between the ages of 4–12 years with > 75 % choanal obstruction on primary nasal endoscopy were recruited in this r and omized , placebo-controlled trial and r and omly divided into two groups . The study group was treated with montelukast 5 mg daily for 12 weeks while the control group received matching placebo for the same period of time . A question naire was completed by each child ’s parent/guardian to assess the severity of sleep discomfort , snoring , and mouth breathing before and after the intervention . Results : Adenoid size decreased in 76 % of the study group compared with 3 % of the placebo group after 12 weeks . A statically significant improvement was observed in the study group compared with the placebo group in terms of sleep discomfort , snoring , and mouth breathing . The symptoms average total score dropped from 7.7 to 3.3 in the study group , while in the placebo group the total score changed from 7.4 to 6.7 . Conclusion : Montelukast chewable tablets achieved a significant reduction in adenoid size and improved the related clinical symptoms of AH and can therefore be considered an effective alternative to surgical treatment in children with adenoid hypertrophy Snoring is a sleep phenomenon due to the partial upper airway obstruction during sleep which causes vibration of the tissues of the rhino-oro-hypopharynx and less frequently the larynx . This study evaluated the use and effectiveness of the erbium : YAG 2940-nm laser as an adjunctive in providing treatment for patients suffering from chronic snoring-related sleep disorders . A prospect i ve study of 40 consecutive patients with snoring and sleep disorders was performed , assessing data before and after three Er : YAG laser treatment sessions . During laser treatment , the pain was almost absent . There were no side effects , except a very mild sore throat in 1 out of 40 patients . The patient ’s evaluation of satisfaction of the results obtained after the treatments showed that 85 % of cases were very satisfied , 5 patients ( 12.5 % ) reported being fairly satisfied with the treatment and only 1 subject ( 2.5 % ) was not satisfied . Mallampati , Friedman Tongue Position , and degree of O ( oropharynx ) at nose oropharynx hypopharynx and larynx classification were significantly decreased after the laser sessions . The decrease of Epworth Sleepiness Scale and Visual Analogue Scale for loudness of snoring , waking up during sleep because of snoring , dry mouth on waking , and choking was all statistically significant . The incidence of dreaming during the night also raised significantly ; 30/40 ( 75 % ) of cases perceived less tightness in their throat and better breathing after treatment . These results were stable at 20 months follow-up ( 14–24 q ) in 72 % of cases . Nonsurgical and non-invasive Er : YAG laser treatment demonstrated to be a valid procedure in reducing the loudness of snoring In a prospect i ve study aim ed at evaluating objective ly the compliance with nasal continuous positive airway pressure ( CPAP ) treatment , 233 obstructive sleep apnea ( OSA ) ( apnea index , > 10 apneas/hour ) patients and 36 nonapneic snorers were studied . The compliance to treatment was measured by the mean rate of use of the CPAP device , obtained from a built-in time counter . The follow-up period was 874 + /- 48 in OSA patients and 675 + /- 83 in snorers . CPAP was proposed to all OSA patients but only to those snorers who felt improved after an initial laboratory night on CPAP . Nineteen OSA patients refused CPAP . Of the 214 OSA patients who accepted CPAP , 181 are still on treatment , with a mean daily rate of use of 5.6 + /- 0.1 hours ( mean + /- SEM ) ; 22 patients stopped CPAP after a variable period of time ; 10 patients died and one acromegalic patient was considered cured after hypophysectomy for a pituitary adenoma . Depending upon the definition of acceptable compliance , the compliance rate in this group was between 77 % and 89 % . The mean rate of use was correlated with indices of disease severity ( apnea index , apnea+hypopnea index , minimal SaO2 during sleep , daytime PaO2 , pulmonary artery pressure ) . Thirty-six nonapneic snorers accepted CPAP . In this group , 26 are still on CPAP , with a mean daily rate of use of 5.4 + /- 0.5 hours ; one patient died ; one underwent uvolopalatopharyngoplasty without follow-up ; and eight stopped CPAP . The compliance rate in this group was between 58 % and 78 % . This study shows that CPAP is reasonably accepted by OSA patients as well as by nonapneic snorers . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVES To develop and vali date a new risk-of-bias tool for nonr and omized studies ( NRSs ) . STUDY DESIGN AND SETTING We developed the Risk of Bias Assessment Tool for Nonr and omized Studies ( RoBANS ) . A validation process with 39 NRSs examined the reliability ( interrater agreement ) , validity ( the degree of correlation between the overall assessment s of RoBANS and Method ological Index for Nonr and omized Studies [ MINORS ] , obtained by plotting the overall risk of bias relative to effect size and funding source ) , face validity with eight experts Output:	There were minimal side effects without serious adverse effects . Er : YAG laser is shown to be effective in a way to reduce snoring without significant AHI or RDI changes .
MS2645	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A prospect i ve , r and omized , cross-over trial was performed to compare the efficacy of nasal intermittent positive-pressure ventilation with nasal continuous positive airway pressure in infants of less than 32 weeks of gestation . Continuous positive airway pressure was delivered at end-expiratory pressures of 4 cm H2O , while peak pressures of 20 cm H2O and end-expiratory pressures of 4 cm H2O were used during nasal intermittent positive-pressure ventilation at ventilatory rates of 20 breaths per minute . The frequency and extent of apnea and bradycardia during a 6-hour period in a patient receiving nasal continuous positive airway pressure were compared with a similar crossover period of nasal intermittent positive-pressure ventilation . Although the infants had slightly less frequent episodes of apnea per hour ( 0.6 + /- 0.7 vs 0.5 + /- 0.7 ) and bradycardia per hour ( 1.2 + /- 1.3 vs 0.9 + /- 1.0 ) during nasal intermittent positive-pressure ventilation , these differences were not significant . There were no significant differences in the severity of these events as assessed by the duration and fall in transcutaneous oxygen pressure during apnea and heart rate during bradycardia . There were no significant changes in blood gases throughout the study . Nasal intermittent positive-pressure ventilation appears to have no advantages over nasal continuous positive airway pressure in preventing apnea and does not alter gas exchange in infants of less than 32 weeks of gestation CONTEXT : Strategies for reducing exposure to endotracheal ventilation through the use of early noninvasive ventilation has proven to be safe and effective , but the option with the greatest benefits needs to be determined . OBJECTIVE : To determine , in infants with respiratory distress syndrome , if early nasal intermittent positive-pressure ventilation ( NIPPV ) compared with nasal continuous positive airway pressure ( NCPAP ) decreases the need for mechanical ventilation . PATIENTS AND METHODS : In this single-center , r and omized controlled trial , infants ( gestational ages 26 to 3367 weeks ) with respiratory distress syndrome were r and omly assigned to receive early NIPPV or NCPAP . Surfactant was administered as rescue therapy . The primary outcome was the need for mechanical ventilation within the first 72 hours of life . RESULTS : A total of 200 infants , 100 in each arm , were r and omly assigned . Rates of the primary outcome did not differ significantly between the NIPPV ( 25 % ) and NCPAP ( 34 % ) groups ( relative risk [ RR ] : 0.71 [ 95 % confidence interval ( CI ) : 0.48–1.14 ] ) . In posthoc analysis , from 24 to 72 hours of life , significantly more infants in the NIPPV group remained extubated compared with those in the NCPAP groups ( 10 vs 22 % ; RR : 0.45 [ 95 % CI : 0.22–0.91 ] ) . This difference was also noted in the group of infants who received surfactant therapy , NIPPV ( 10.9 % ) , and NCPAP ( 27.1 % ) ( RR : 0.40 [ 95 % CI : 0.18–0.86 ] ) . CONCLUSIONS : Early NIPPV did not decrease the need for mechanical ventilation compared with NCPAP , overall , in the first 72 hours of life . However , further studies to assess the potential benefits of noninvasive ventilation are warranted , especially for the most vulnerable or preterm infants Objective : Comparison of outcomes of infants with respiratory distress syndrome ( RDS ) , post-surfactant , extubated to synchronized nasal intermittent positive pressure ventilation ( SNIPPV ) or continued on conventional ventilation ( CV ) . Study Design : Prospect i ve post-surfactant r and omized controlled trial of primary mode SNIPPV compared with CV in infants ( born from July 2000 to March 2005 ) with birth weights ( BW ) of 600 to 1250 g. Primary mode SNIPPV was defined as its use in the acute phase of RDS , following the administration of the first dose of surfactant . Result : There were no significant differences in the maternal demographics , antenatal steroid use , mode of delivery , BW , gestational age , gender or Apgar at 5 min between infants continued on CV ( n=21 ) and those extubated to primary mode SNIPPV ( n=20 ) . Significantly , more babies in the CV group had the primary outcome of bronchopulmonary dysplasia (BPD)/death , compared to the SNIPPV group ( 52 versus 20 % , P=0.03 ) . There was no difference in the incidence of other common neonatal morbidities . There were no differences in the Mental or Psychomotor Developmental Index scores on follow-up between the two groups . Conclusion : Infants of BW 600 to 1250 g with RDS receiving surfactant with early extubation to SNIPPV had a significantly lower incidence of BPD/death . Primary mode SNIPPV is a feasible method of ventilation in small premature infants OBJECTIVE To compare the rate of reintubation within 7 days after extubation and study the complications in premature infants who were r and omized in the immediate postextubation period to either nsNIMV or NCPAP . MATERIAL AND METHOD This study was conducted in the neonatal unit of Queen Sirikit National Institute of Child Health between June 1 and November 30 , 2006 . Intubated premature infants born at GA < or = 34 weeks or with birth weight < or = 1500 gm , ready to be extubated before 4 weeks of age were recruited . Infants were r and omized to either nsNIMV or NCPAP after extubation . Non-synchronized NIMV setting was the same as ventilator setting before extubation and NCPAP pressure was set at the same mean airway pressure of pre extubation ventilator value . Extubation was performed after intravenous loading dose of aminophylline . Primary outcome measurement was reintubation within 7 days of initial extubation and the secondary outcome was possible complications such as apnea , abdominal distension , gastrointestinal ( GI ) perforation , necrotizing enterocolitis ( NEC ) , sepsis and death . RESULTS A total of 70 VLBW infants were admitted to the neonatal unit during the study period . A total of 57 infants were intubated of which 48 infants were recruited for the study ; 24 were in the nsNIMV group and 24 were in the NCPAP group . Infants in the nsNIMV group had mean birth weight and body weight at the start of study less than that in the NCPAP group ( 984.8 + /- 218 vs. 1067 + /- 214 and 1185 + /- 219 vs. 1205 + /-191 , p = 0.003 , 0.02 ) . The nsNIMV group also had a higher rate of RDS and antenatal steroid used when compared to the NCPAP group ( 19/24 vs. 12/24 and 17/24 vs. 8/24 , p = 0.03 , 0.01 ) . The nsNIMV group had fewer males than in the NCPAP group ( 8/24 vs. 17/24 , p = 0.01 ) . Reintubation was similar in both groups but atelectasis and sepsis were statistically significant risk factor for reintubation in NCPAP group . There were no significant differences in treatment related complications between the two groups , with respect to incidence of apnea ( 41.7 % in nsNIMV vs. 62.5 % in NCPAP ) , abdominal distensions ( 8.3 % in nsNIMVvs . 16.7 % in NCPAP ) , NEC ( 4.2 % in nsNIMVvs . 12.5 in NCPAP ) , sepsis ( 4.2 % in nsNIMVvs . 8.3 % NCPAP ) . No GI perforation was observed in both groups . CONCLUSION Non-invasive mode of ventilation , both NIMV and NCPAP , for weaning ofpre-term infants from ventilator may reduce the rate of reintubation in this group . Both modes seem to be equally safe . We believe that the use of non-invasive ventilator techniques will significantly reduce neonatal morbidity in the future . Additional prospect i ve evaluation of these approaches should be conducted in the future OBJECTIVE To determine whether synchronized nasal intermittent positive pressure ventilation ( SNIPPV ) would decrease extubation failure compared with nasal continuous positive airway pressure ( NCPAP ) in preterm infants being ventilated for respiratory distress syndrome ( RDS ) . METHODS Infants who were < /=34 weeks ' gestational age and who were ventilated for RDS were r and omized to either SNIPPV or NCPAP after extubation . The criteria for extubation were peak inspiratory pressure of < /=16 cm H(2)O , positive end expiratory pressure of < /=5 cm H(2)O , intermittent m and atory ventilation rate of 15 to 25 , and fraction of inspired oxygen < /=0.35 . Pulmonary function tests ( PFT ) were obtained before extubation . After extubation , blood gases were monitored for a minimum of 72 hours . Success was defined as remaining in the selected mode of treatment or demonstrating improvement ( switching to oxyhood/nasal cannula/room air ) by 72 hours . RESULTS Thirty-two ( 94 % ) of 34 infants were extubated successfully with the use of SNIPPV versus 18 ( 60 % ) of 30 with the use of NCPAP ( P < .01 ) . There was no difference in apnea/bradycardia episodes in the 2 groups during the 72-hour study period . Among 55 infants who had PFT , 80 % ( 8 of 10 ) with dynamic lung compliance of > /=0.5 mL/kg/cm H(2)O and expiratory airway resistance of < /=70 cm H(2)O/L/s were extubated successfully . In infants with poor lung function ( dynamic lung compliance : < 0.5 mL/kg/cm H(2)O ; expiratory airway resistance : > 70 cm H(2)O/L/s ) , successful extubation was seen in 93 % ( 27 of 29 ) in the SNIPPV group and 60 % ( 15 of 25 ) in the NCPAP group . When weight was controlled for at the time of extubation , the odds of success in the SNIPPV group were 21.1 times higher ( 95 % confidence interval : 3.4 , 130.1 ) than that of the NCPAP group . CONCLUSIONS SNIPPV is more effective than NCPAP in weaning infants with RDS from the ventilator . PFT may be useful in predicting successful extubation OBJECTIVE : To compare the outcome of infants with respiratory distress syndrome ( RDS ) in the neonatal intensive care unit ( NICU ) who were extubated to synchronized nasal intermittent positive pressure ventilation ( SNIPPV ) or continued on conventional ventilation ( CV ) , immediately postsurfactant . STUDY DESIGN : Prospect i ve observational study of postsurfactant ventilatory management of consecutive infants ( born between 10/99 and 12/02 ) of 28 to 34 weeks gestation . Extubation to SNIPPV was at the attending neonatologists ' discretion . Babies in the CV group remained intubated , postsurfactant . RESULTS : There were no significant differences in the maternal demographics , antenatal steroid use , mode of delivery , birth weight ( BW ) , gestational age ( GA ) , gender , Apgar at 5 minutes , age at surfactant instillation , or oxygenation index ( OI ) prior to surfactant administration , between infants continued on CV ( n=35 ) and those extubated to SNIPPV ( n=24 ) . The total duration of endotracheal intubation ( mean±SEM ; CV versus SNIPPV ; 2.4±0.4 versus 0.3±0.0 days , p=0.001 ) and duration of supplemental oxygen exposure ( 15±3.2 versus 8.2±3.3 days , p=0.04 ) were significantly shorter in the SNIPPV group . Furthermore , the duration of parenteral nutrition ( 12.1±1.6 versus 8.4±0.8 days , p=0.02 ) and length of stay ( 37.5±3.0 versus 29.1±3.3 days , p=0.04 ) were also significantly shorter in the SNIPPV group . There were no differences between the two groups in blood gas or OI values postsurfactant ( up to 48 hours ) . There was no statistical difference in the incidence of intraventricular hemorrhage grade I ( three ( 9 % ) in the CV group and two infants ( 8 % ) in the SNIPPV group ) . No infant died in either group or had patent ductus arteriosus , air leaks , necrotizing enterocolitis , periventricular leukomalacia , retinopathy of prematurity or bronchopulmonary dysplasia . CONCLUSIONS : Infants of 28 to 34 weeks GA with RDS requiring surfactant with early extubation to SNIPPV had a shorter duration of intubation , and decreased need for oxygen as compared to CV . There was also a significant decrease in the duration of parenteral Output:	Conclusions NIPPV could be used to reduce endotracheal ventilation , increase successful extubation , decrease the rate of apnea of prematurity , and have better outcome indicated by fewer death and /or bronchopulmonary dysplasia in preterm and term newborn infants
MS2646	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Prior peripheral hypoxia induced via remote ischemic preconditioning ( IPC ) can improve physical performance in male athletes through improved O2 delivery and utilization . Since females may have an innate protective mechanism against ischemia-reperfusion injury , and since muscle metabolism during contraction differs between sexes , it is relevant to examine the impact of sex in response to IPC to determine whether it is also ergogenic in females . In a r and omized , crossover , single-blind study , we investigated muscle performance , hemodynamic and O2 uptake in strength-trained males ( n = 9 ) and females ( n = 8) performing five sets of 5 maximum voluntary knee extensions on an isokinetic dynamometer , preceded by either IPC ( 3 × 5-min ischemia/5-min reperfusion cycles at 200 mmHg ) or SHAM ( 20 mmHg ) . Changes in deoxy-hemoglobin ( Δ[HHb ] , expressed in percentage of arterial occlusion and considered an index of O2 extraction ) , and total hemoglobin ( Δ[THb ] ) concentrations of the vastus lateralis muscle were continuously monitored by near-infrared spectroscopy . The metabolic efficiency of the contractions was calculated as the average force/Δ[HHb]avg ratio . Cohen 's effect sizes ( ES ) ± 90 % confidence limits were used to estimate IPC-induced changes and sex differences . IPC increased total muscular force in males only ( 13.0 % , ES 0.64 , 0.37;0.90 ) , and this change was greater than in females ( 10.4 % difference , ES 0.40 , 0.10;0.70 ) . Percent force decrement was only attenuated in females ( −19.8 % , ES −0.38 , −0.77;0.01 ) , which was clearly different than males ( sex difference : ES 0.45 , −0.16;1.07 ) . IPC also induced different changes between sexes for average muscle O2 uptake in set 2 ( males : 6.4 % vs. females : −16.7 % , ES 0.21 , −0.18;0.60 ) , set 3 ( males : 7.0 % vs. females : −44.4 % , ES 0.56 , −0.17;1.29 ) , set 4 ( males : 9.1 % vs. females : −40.2 % , ES 0.51 , −0.10;1.13 ) , and set 5 ( males : 10.2 % vs. females : −40.4 % , ES 0.52 , −0.04;1.09 ) . However , metabolic efficiency was not meaningfully different between conditions and sexes . IPC increased muscle blood volume ( ↑[THb ] ) at rest and during recovery between sets , to the same extent in both sexes . Despite a similar IPC-induced initial increase in O2 delivery in both sexes , males displayed greater peripheral O2 extraction and greater strength enhancement . This ergogenic effect appears to be mediated in part via an up regulated oxidative function in males . We conclude that strength-trained males might benefit more from IPC than their female counterparts during repeated , maximal efforts The potential purpose of near‐infrared spectroscopy ( NIRS ) as a clinical application in patients with chronic heart failure ( CHF ) is the identification of limitations in O2 delivery or utilization during exercise . The objective of this study was to evaluate absolute and relative test – retest reliability of skeletal muscle oxygenation measurements in patients with CHF . Thirty patients with systolic heart failure ( left ventricular ejection fraction 31 ± 8 % ) performed 6‐min constant‐load cycling tests at 80 % of the anaerobic threshold ( AT ) with tissue saturation index ( TSI ) measurement at the vastus lateralis . Tests were repeated after 10 ± 5 days to evaluate reliability . Absolute reliability was assessed with limits of agreement ( LoA , expressed as bias ± r and om error ) and coefficients of variation ( CV ) for absolute values ( LoA range : 0·4 ± 6·2 % to 0·6 ± 7·9 % ; CV range : 4·7–7·1 % ) , amplitudes ( LoA range −0·5 ± 5·8 % to −0·7 ± 6·8 % ; CV range : 26·2–42·1 % ) , onset and recovery kinetics ( mean response times ; LoA 0·4 ± 9·5 s , CV 23·5 % and LoA −5·8 ± 50·8 s , CV 67·4 % respectively ) and overshoot characteristics ( CV range 45·7–208·6 % ) . Relative reliability was assessed with intraclass correlation coefficients for absolute values ( range 0·74–0·90 ) , amplitudes ( range 0·85–0·92 ) , onset and recovery kinetics ( 0·53 and 0·51 , respectively ) and overshoot characteristics ( range 0·17–0·74 ) . In conclusion , absolute reliability of absolute values and onset kinetics seems acceptable for serial within‐subject comparison , and as such , for evaluation of treatment effects . Absolute reliability of amplitudes and recovery kinetics is considered unsatisfactory . Relative reliability of absolute values and amplitudes is sufficient for purpose s of physiological distinction between patients with CHF . Despite lower relative reliability , kinetics may still be useful for clinical application This study examined the effects of Sprint Interval Cycling ( SIT ) on muscle oxygenation kinetics and performance during the 30 - 15 intermittent fitness test ( IFT ) . Twenty-five women hockey players of Olympic st and ard were r and omly selected into an experimental group ( EXP ) and a control group ( CON ) . The EXP group performed six additional SIT sessions over six weeks in addition to their normal training program . To explore the potential training-induced change , EXP subjects additionally completed 5 x 30s maximal intensity cycle testing before and after training . During these tests near-infrared spectroscopy ( NIRS ) measured parameters ; oxyhaemoglobin + oxymyoglobin ( HbO2 + MbO2 ) , tissue deoxyhaemoglobin + deoxymyoglobin ( HHb+HMb ) , total tissue haemoglobin ( tHb ) and tissue oxygenation ( TSI % ) were taken . In the EXP group ( 5.34±0.14 to 5.50±0.14m.s-1 ) but not the CON group ( pre = 5.37±0.27 to 5.39±0.30m.s-1 ) significant changes were seen in the 30 - 15IFT performance . EXP group also displayed significant post-training increases during the sprint cycling : ΔTSI ( −7.59±0.91 to −12.16±2.70 % ) ; ΔHHb+HMb ( 35.68±6.67 to 69.44±26.48μM.cm ) ; and ΔHbO2 + MbO2 ( −74.29±13.82 to −109.36±22.61μM.cm ) . No significant differences were seen in ΔtHb ( −45.81±15.23 to −42.93±16.24 ) . NIRS is able to detect positive peripheral muscle oxygenation changes when used during a SIT protocol which has been shown to be an effective training modality within elite athletes Introduction : The aim of this study was to determine whether calf compression sleeves ( CS ) affects physiological and biomechanical parameters , exercise performance , and perceived sensations of muscle fatigue , pain and soreness during prolonged ( ~2 h 30 min ) outdoor trail running . Methods : Fourteen healthy trained males took part in a r and omized , cross-over study consisting in two identical 24-km trail running sessions ( each including one bout of running at constant rate on moderately flat terrain , and one period of all-out running on hilly terrain ) wearing either degressive CS ( 23 ± 2 mmHg ) or control sleeves ( CON , < 4 mmHg ) . Running time , heart rate and muscle oxygenation of the medial gastrocnemius muscle ( measured using portable near-infrared spectroscopy ) were monitored continuously . Muscle functional capabilities ( power , stiffness ) were determined using 20 s of maximal hopping before and after both sessions . Running biomechanics ( kinematics , vertical and leg stiffness ) were determined at 12 km·h−1 at the beginning , during , and at the end of both sessions . Exercise-induced Achilles tendon pain and delayed onset calf muscles soreness ( DOMS ) were assessed using visual analog scales . Results : Muscle oxygenation increased significantly in CS compared to CON at baseline and immediately after exercise ( p < 0.05 ) , without any difference in deoxygenation kinetics during the run , and without any significant change in run times . Wearing CS was associated with ( i ) higher aerial time and leg stiffness in running at constant rate , ( ii ) with lower ground contact time , higher leg stiffness , and higher vertical stiffness in all-out running , and ( iii ) with lower ground contact time in hopping . Significant DOMS were induced in both CS and CON ( > 6 on a 10-cm scale ) with no difference between conditions . However , Achilles tendon pain was significantly lower after the trial in CS than CON ( p < 0.05 ) . Discussion : Calf compression did not modify muscle oxygenation during ~2 h 30 of trail running but significantly changed running biomechanics and lower limb muscle functional capabilities toward a more dynamic behavior compared to control session . However , wearing compression sleeves did not affect performance and exercise-induced DOMS , while it minimized Achilles tendon pain immediately after running The effects of intermittent hypoxic exposure ( IHE ) on cerebral and muscle oxygenation , arterial oxygen saturation ( SaO2 ) , and respiratory gas exchange during a 20-km cycle time trial ( 20TT ) were examined ( n=9 ) in a placebo-controlled r and omized design . IHE ( 7:3 min hypoxia to normoxia ) involved 90-min sessions for 10 days , with SaO2 clamped at ~80 % . Prior to , and 2 days after the intervention , a 20TT was performed . During the final minute of the 20TT , in the IHE group only , muscle oxyhemoglobin ( oxy-Hb ) was elevated ( mean+/-95 % confidence interval 1.3+/-1.2 ΔmicroM , p=0.04 ) , whereas cerebral oxy-Hb was reduced ( -1.9%+/-1.0 % , p<0.01 ) post intervention compared with baseline . The 20TT performance was unchanged between groups ( p=0.7 ) . In the IHE group , SaO2 was higher ( 1.0+/-0.7Δ% , p=0.006 ) and end-tidal PCO2 was lower ( -1.2+/-0.1 mm Hg , p=0.01 ) during the final stage of the 20TT post intervention compared with baseline . In summary , reductions in muscle oxy-Hb and systemic SaO2 occurring at exercise intensities close to maximal at the end of a 20TT were offset by IHE , although this was not translated into improved performance Abstract In this study , we wished to determine whether the observed reduction in quadriceps muscle oxygen availability , reported during repetitive bouts of isometric exercise in simulated sailing efforts ( i.e. hiking ) , is because of restricted muscle blood flow . Six national-squad Laser sailors initially performed three successive 3-min hiking bouts followed by three successive 3-min cycling tests sustained at constant intensities reproducing the cardiac output recorded during each of the three hiking bouts . The blood flow index ( BFI ) was determined from assessment of the vastus lateralis using near-infrared spectroscopy in association with the light-absorbing tracer indocyanine green dye , while cardiac output was determined from impedance cardiography . At equivalent cardiac outputs ( ranging from 10.3±0.5 to 14.8±0.86 L · min−1 ) , the increase from baseline in vastus lateralis BFI across the three hiking bouts ( from 1.1±0.2 to 3.1±0.6 nM · s−1 ) was lower ( P = 0.036 ) than that seen during the three cycling bouts ( from 1.1±0.2 to 7.2±1.4 nM · s−1 ) ( Cohen 's d : 3.80 nM · s−1 ) , whereas the increase from baseline in deoxygenated haemoglobin ( by ∼17.0±2.9 μM ) ( an index of tissue oxygen extraction ) was greater ( P = 0.006 ) during hiking than cycling ( by ∼5.3±2.7 μM ) ( Cohen 's d : 4.17 μM ) . The results suggest that reduced vastus lateralis muscle oxygen availability during hiking arises from restricted muscle blood flow in the isometrically acting quadriceps muscles Muscle ischemia and reperfusion induced by ischemic preconditioning ( IPC ) can improve performance in various activities . However , the underlying mechanisms are still poorly understood . The purpose of this study was to examine the effects of IPC on muscle hemodynamics and oxygen ( O2 ) uptake during repeated maximal contractions . In a cross-over , r and omized , single-blind study , 10 strength-trained men performed 5 sets of 5 maximal voluntary knee extensions of the right leg on an isokinetic dynamometer , preceded by either IPC of the right lower limb ( Output:	This systematic review highlighted a number of key findings in 16 sporting activities . Overall , NIRS information can be used as a marker of skeletal muscle oxidative capacity and for analyzing muscle performance factors .
MS2647	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials STUDY OBJECTIVES The purpose s of this study were as follows : ( 1 ) to determine whether physical performance , quality of life , and dyspnea with activities of daily living improved following both short-term and long-term pulmonary rehabilitation ( PR ) across multiple hospital outpatient programs ; ( 2 ) to examine the differences in these parameters between men and women ; and ( 3 ) to determine what relationships existed between the psychosocial parameters and the results of the 6-min walk ( 6MW ) test performance across programs . DESIGN Non-experimental , prospect i ve , and comparative . SETTING Seven outpatient hospital PR programs from urban and rural setting s across North Carolina . PARTICIPANTS Three hundred nine women and 281 men who were 20 to 93 years of age ( mean [ + /- SD ] age , 66.7 + /- 11.1 years ) with chronic lung disease . INTERVENTIONS All 6MW tests and health surveys were administered prior to and immediately following 12 and 24 weeks of supervised PR participation . Scores from the 6MW tests , the Ferrans and Powers quality of life index-pulmonary version III ( QLI ) , the Medical Outcomes Study 36-item short form ( SF-36 ) , and the University of California at San Diego shortness of breath question naire ( SOBQ ) were compared at PR entry , at 12 weeks , and at 24 weeks for differences by gender with repeated- measures analysis of variance . The study entry and follow-up SF-36 physical and mental component summary scores , the QLI health/function and overall scores , and the SOBQ scores were also compared to the 6MW test scores with Pearson correlation coefficient analysis . RESULTS The mean summary scores on the SF-36 and the QLI increased after 12 weeks of PR ( p < 0.05 ) , and improvements were maintained by 24 weeks of PR participation ( p < 0.05 ) . Scores on the SOBQ improved after 12 weeks ( p < 0.001 ) among the short-term participants , but not until after 24 weeks among the long-term participants ( p = 0.009 ) . The 6MW test performance improved after 12 weeks ( p < 0.001 ) and again from 12 to 24 weeks ( p = 0.002 ) in the long-term participants . No relevant correlational relationships were found between 6MW scores and the summary scores of the administered surveys ( r = -0.43 to 0.36 ) . CONCLUSIONS Physical performance , as measured by the 6MW test , continued to improve with up to 24 weeks of PR participation . Quality -of-life measures and the perception of dyspnea improved after 12 weeks of PR participation , with improvements maintained by 24 weeks of PR participation . It is recommended that PR patients participate in supervised PR for at least 24 weeks to gain and maintain optimal health benefits The purpose of this study was to investigate the effects on activities of daily living , quality of life , and exercise tolerance of a comprehensive out-patient rehabilitation programme for patients with moderate-to-severe chronic obstructive pulmonary disease . In this r and omized and controlled trial , the main outcome measures were Activities of Daily Living ( ADL ) score , York Quality of Life Question naire ( YQLQ ) score , Chronic Respiratory Disease Question naire ( CRDQ ) score , 6 min walking distance ( 6MWD ) , forced expiratory volume in one second ( FEV1 ) , and forced vital capacity ( FVC ) . The rehabilitation programme included physical training , occupational therapy , education , and smoking cessation therapy , and lasted for 12 weeks . The patients were evaluated at entry , halfway through , and at the end of the programme . Follow-up was at 24 weeks . Forty seven patients were recruited , and 16 in each group completed the trial . There were significant differences in the improvements in ADL and CRDQ between the control and the treatment groups at 12 and 24 weeks , and at 24 weeks , respectively . At 6 , 12 and 24 weeks , improvements in the 6MWD were 21.6 versus 79.8 , 36.1 versus 113.1 and 21.4 versus 96.2 for control and treatment groups , respectively ( p<0.004 ) . A correlation matrix showed only ADL and 6MWD to be significantly correlated ; the matrix was also used to vali date the translated question naires . The programme required 124 staff-hours in total . An inexpensive , comprehensive out-patient rehabilitation programme can produce long-term improvement in activities of daily living , quality of life , and exercise tolerance in patients with moderate-to-severe chronic obstructive pulmonary disease Maintenance of physical activity following pulmonary rehabilitation remains a challenge for patients with chronic obstructive pulmonary disease ( COPD ) . The objectives of this study were to identify patterns of endurance activity after completion of pulmonary rehabilitation and to characterise people who succeed and those who have difficulty maintaining endurance activity . In a longitudinal study embedded within a r and omised clinical trial , 206 individuals with COPD underwent a 3-month pulmonary rehabilitation programme . Weekly duration of endurance activity was assessed at 4 , 6 , 8 and 12 months after the start of rehabilitation . Trajectory modelling was used to determine the most common patterns of activity during the post-rehabilitation phase from 4–12 months . Three distinct patterns were identified , two of which indicated difficulty in maintaining endurance activity : 61 individuals reported a high activity level at 4 months ( 2.7 h·week−1 ) and stayed high ; 114 individuals started at a low activity level ( mean 1.0 h·week−1 ) and stayed low ; and 31 individuals started high ( 3.0 h·week−1 ) and declined . The low activity group was characterised by more severe disease and greater respiratory impairment . The high and declined group had less severe disease and respiratory impairment , but reported greater barriers to exercise . Pulmonary rehabilitation should include interventions aim ed at minimising barriers , in order to induce long-term behaviour change OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity The aim of this study was to evaluate the short-term benefits of a pulmonary rehabilitation program in chronic obstructive pulmonary disease ( COPD ) patients . The study was a r and omized controlled trial that included 54 mild and moderate COPD patients . Patients were assigned to either an 8-week-long pulmonary rehabilitation program , which consisted of exercise plus education ( rehabilitation group ) , or were controls . All the patients were evaluated at baseline at the completion of the 8th week of the program and one month after the completion of the pulmonary rehabilitation program using five instruments : arterial blood gas analysis , postbronchodilator pulmonary function test , 6-minute walk test ( 6MWT ) , Saint George Respiratory Question naire ( SGRQ ) , and the dyspnea visual analog scale ( VAS ) There were no statistically significant differences in the pulmonary functions and pulmonary gas analysis between baseline , discharge ( 8th week ) , and the 12th-week visit in both groups ( p > 0.05 ) . Rehabilitation result ed in significant improvements in both the VAS and the 6MWT at the 8th week , but by the 12th week all of these improvements had deteriorated . All of the SGRQ domains improved both at the 8th and the 12th week , with a significant difference between the groups ( p < 0.05 ) . We conclude that rehabilitation result ed in improvements in exercise capacity , health status , and dyspnea . All of these benefits , however , tend to deteriorate in the first month after rehabilitation . Therefore , it is strongly recommended that all patients with COPD be kept motivated in order to continue with rehabilitation and maintain the benefits gained UNLABELLED The central purpose of pulmonary rehabilitation is to reduce morbidity by improving functional capacity through exercise . It is still unknown if improvements in functional capacity are maintained in the long-term and if this leads to increased physical activity levels as measured by a free-living activity monitor . The hypothesis of this study was that pulmonary rehabilitation would lead to a sustained increase in st and ard outcome measures and in daily physical activity . METHODS A prospect i ve study of 47 subjects with COPD was performed , registered at Clinical Trials.gov ( Clinical Trial Number NCT 0112943 ) . The primary outcome was a maintained improvement in st and ard outcome measures with a secondary aim of an increase in daily physical activity . A convenient sample of the cohort ( n = 17 ) was re-evaluated at a third time point at 1 year . RESULTS A seven week hospital based outpatient pulmonary rehabilitation program led to a significant reduction in total energy expenditure ( p < 0.044 ) and breathlessness ( Borg , p < 0.011 ) and improved exercise capacity ( ISWT , p > 0.001 , 6MWT , p > 0.002 ) PiMax ( p > 0.007 ) and quality of life scores ( SGRQ , p > 0.001 , EQ5D , 0.025 ) . However , pulmonary rehabilitation did not significantly change the average number of daily steps taken , time spent sedentary activity , METs consumed or daily physical activity . Indeed , all of the st and ard and freeliving values had returned towards the baseline value at 1 year . DISCUSSION These findings show that while pulmonary rehabilitation increased exercise capacity this was not transmitted into increased daily physical activity . Hence , alternative methods to alter/affect behavioural change need to be addressed OBJECTIVE To establish the minimal important difference ( MID ) for the six-minute walk distance ( 6MWD ) in persons with chronic obstructive pulmonary disease ( COPD ) . DESIGN Analysis of data from an observational study using distribution- and anchor-based methods to determine the MID in 6MWD . SETTING Outpatient pulmonary rehabilitation program at 2 teaching hospitals . PARTICIPANTS Seventy-five patients with COPD ( 44 men ) in a stable clinical state with mean age 70 years ( SD 9 y ) , forced expiratory volume in one second 52 % ( SD 21 % ) predicted and baseline walking distance 359 meters ( SD 104 m ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Participants completed the six-minute walk test before and after a 7-week pulmonary rehabilitation program . Participants and clinicians completed a global rating of change score while blinded to the change in 6MWD . RESULTS The mean change in 6MWD in participants who reported themselves to be unchanged was 17.7 meters , compared with 60.2 meters in those who reported small change and 78.4 meters in those who reported substantial change ( P=.004 ) . Anchor-based methods identified an MID of 25 meters ( 95 % confidence Output:	Reported relationships were facilitated by healthcare professionals , social supporters , motivation and encouragement , reduced fear and seeing benefits and hindered by changing physical health , environment , lack of motivation , fear and social isolation . The associations between increased levels of PA and quality of life , respiratory function and dyspnoea are largely based on 6MWD and PA question naires . Initial benefits from PR decline after program completion . Following PR , increased levels of physical activity in people with COPD undertaking exercise maintenance programmes are positively related with improvements in exercise capacity , quality of life and dyspnoea .
MS2648	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: UNLABELLED Human immunodeficiency virus (HIV)/hepatitis C virus ( HCV ) coinfection is associated with progressive liver disease . However , the rate of progression is variable and the ability to differentiate patients with stable versus progressive HCV disease is limited . The objective of this study was to assess the incidence of and risk factors for fibrosis progression in a prospect i ve cohort of coinfected patients . Overall , 435 liver biopsy pairs from 282 patients without cirrhosis were analyzed . Biopsies were scored according to the METAVIR system by a single pathologist blind to biopsy sequence . Fibrosis progression was defined as an increase of at least one METAVIR fibrosis stage between paired biopsies . The majority of patients were African American ( 84.8 % ) , male ( 67.7 % ) , and infected with HCV genotype 1 ( 93.4 % ) . On initial biopsy , no or minimal fibrosis was identified in 243 patients ( 86 % ) . The median interval between biopsies was 2.5 years . Fibrosis progression was observed in 97 of 282 ( 34 % ) patients and 149 of 435 ( 34 % ) biopsy pairs . After adjustment , greater body mass index ( adjusted odds ratio [ aOR ] : 1.04 per 1 unit increase ) , diabetes ( aOR : 1.56 ) , and hepatic steatosis ( aOR : 1.78 ) at the time of initial biopsy were marginally associated with subsequent fibrosis progression . Between biopsies , elevated serum aspartate and alanine aminotransferase ( AST , ALT ) ( aOR AST : 3.34 , ALT : 2.18 for > 25 % values > 100 U/L versus < 25 % values > 100 U/L ) were strongly associated with fibrosis progression . CONCLUSION Fibrosis progression is common among HIV/HCV coinfected patients ; these data suggest that progression can be rapid . Persistent elevations in serum transaminase levels may serve as important noninvasive markers to identify subsets of patients who are more likely to progress and thus warrant closer monitoring and consideration of HCV treatment BACKGROUND FibroTest , a noninvasive method of measuring biomarkers of liver fibrosis , is an alternative to liver biopsy for determining the severity of chronic hepatitis C virus ( HCV ) infection . We compared the 5-year prognostic value of the FibroTest with biopsy staging for predicting cirrhosis decompensation and survival in patients with chronic HCV infection . METHODS Fibrosis stage was assessed on the same day by FibroTest and biopsy in a prospect i ve cohort of 537 patients . Disease classification at baseline was 157 patients with severe fibrosis ( FibroTest > 0.58 ) , 137 with moderate fibrosis ( FibroTest 0.32 - 0.58 ) , and 243 with no or minimal fibrosis ( FibroTest < 0.32 ) . RESULTS In 64 untreated patients with severe fibrosis , survival without HCV complications was 73 % [ 95 % confidence interval ( CI ) , 59%-086 % ; 13 complications ] , and survival without HCV-related death was 85 % ( 95 % CI , 73%-96 % ; 7 HCV deaths ) . Survival rates were higher in patients with moderate fibrosis , [ 99 % ( 95 % CI , 97%-100 % ; 1 complication ; P < 0.001 ) and 100 % ( no HCV death ; P < 0.001 ) for patients with and without HCV-related complications , respectively ] , and in patients with minimal fibrosis [ 100 % ( no complication ; P < 0.001 vs severe ) and 100 % ( no HCV death ; P < 0.001 vs severe ) , respectively ] . FibroTest was a better predictor than biopsy staging for HCV complications , with area under the ROC curves ( AUROC ) = 0.96 ( 95 % CI , 0.93%-0.97 % ) vs 0.91 ( 95 % CI , 0.85%-0.94 % ; P = 0.01 ) , respectively ; it was also a better predictor for HCV deaths : AUROC = 0.96 ( 95 % CI , 0.93%-0.98 % ) vs 0.87 ( 95 % CI , 0.70%-0.94 % ; P = 0.046 ) , respectively . The prognostic value of FibroTest was still significant ( P < 0.001 ) in multivariate analyses after taking into account histology , treatment , alcohol consumption , and HIV coinfection . CONCLUSION The FibroTest measurement of HCV biomarkers has a 5-year prognostic value similar to that of liver biopsy IMPORTANCE Patients co-infected with human immunodeficiency virus ( HIV ) and hepatitis C virus ( HCV ) are at high risk for liver disease progression . However , interferon-based treatments for HCV infection have significant toxicities , limiting treatment uptake . OBJECTIVE To assess the all-oral 3 direct-acting antiviral ( 3D ) regimen of ombitasvir , paritaprevir ( co-dosed with ritonavir [ paritaprevir/r ] ) , dasabuvir , and ribavirin in HCV genotype 1-infected adults with HIV-1 co-infection , including patients with cirrhosis . DESIGN , SETTING , AND PARTICIPANTS TURQUOISE-I is a r and omized , open-label study . Part 1a of this pilot study was conducted at 17 sites in the United States and Puerto Rico between September 2013 and August 2014 and included 63 patients with HCV genotype 1 and HIV-1 co-infection who were HCV treatment-naive or had history of prior treatment failure with peginterferon plus ribavirin therapy . The study allowed enrollment of patients , including those with cirrhosis , with a CD4 + count of 200/mm3 or greater or CD4 + percentage of 14 % or more and plasma HIV-1 RNA suppressed while taking a stable atazanavir- or raltegravir-inclusive antiretroviral regimen . INTERVENTIONS Ombitasvir/paritaprevir/r , dasabuvir , and ribavirin for 12 or 24 weeks of treatment as r and omized . MAIN OUTCOMES AND MEASURES The primary assessment was the proportion of patients with sustained virologic response ( HCV RNA < 25 IU/mL ) at posttreatment week 12 ( SVR12 ) . RESULTS Among patients receiving 12 or 24 weeks of 3D and ribavirin , SVR12 was achieved by 29 of 31 ( 94 % ; 95 % CI , 79%-98 % ) and 29 of 32 patients ( 91 % ; 95 % CI , 76%-97 % ) , respectively . Of the 5 patients who did not achieve SVR , 1 withdrew consent , 2 had confirmed virologic relapse or breakthrough , and 2 patients had clinical history and phylogenetic evidence consistent with HCV reinfection . The most common treatment-emergent adverse events were fatigue ( 48 % ) , insomnia ( 19 % ) , nausea ( 18 % ) , and headache ( 16 % ) . Adverse events were generally mild , with none reported as serious or leading to discontinuation . No patient had a confirmed HIV-1 breakthrough of 200 copies/mL or greater during treatment . CONCLUSIONS AND RELEVANCE In this open-label , r and omized uncontrolled study , treatment with the all-oral , interferon-free 3D-plus-ribavirin regimen result ed in high SVR rates among patients co-infected with HCV genotype 1 and HIV-1 whether treated for 12 or 24 weeks . Further phase 3 studies of this regimen are warranted in patients with co-infection . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01939197 BACKGROUND / AIMS To examine if serum fibrosis biomarkers could accurately identify the stage of liver disease amongst hepatitis C ( HCV ) and HIV co-infected patients . METHODS One hundred and thirty seven HIV/HCV co-infected persons were r and omly selected from the Johns Hopkins HIV Clinic cohort . Ninety five had complete testing for fibrosis markers in sera collected at the time of liver biopsy . Biopsies were scored according to Ishak modified histological activity index ( F0 no fibrosis to F6 cirrhosis ) . Fibrosis was evaluated against alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , AST to platelet ratio ( APRI ) , albumin , total bilirubin , hyaluronic acid ( HA ) and YKL-40 . RESULTS Sixty nine ( 73 % ) had no or minimal portal fibrosis ( F0 - 2 ) and were compared with remaining subjects ( F3 - 6 ) . Fibrosis scores > or = F3 were found 27 times more often in persons with HA levels > 86 ng/ml and 5.5 times more often in persons with HA levels 41 - 86 ng/ml . Less substantial associations were detected with levels of albumin < 3.5 g/dl ( OR 4.85 ) and AST > 60 iu ( OR 5.91 ) . All 35 subjects who had favorable results of HA , albumin , and AST had minimal fibrosis ( F0 - 2 ) . CONCLUSIONS Amongst HIV/HCV co-infected patients , serum testing for HA , albumin , and AST ( SHASTA Index ) was able to accurately stage mild and advanced fibrosis Liver biopsy remains the gold st and ard in the assessment of severity of liver disease . Noninvasive tests have gained popularity to predict histology in view of the associated risks of biopsy . However , many models include tests not readily available , and there are limited data from patients with HIV/hepatitis C virus ( HCV ) coinfection . We aim ed to develop a model using routine tests to predict liver fibrosis in patients with HIV/HCV coinfection . A retrospective analysis of liver histology was performed in 832 patients . Liver fibrosis was assessed via Ishak score ; patients were categorized as 0 - 1 , 2 - 3 , or 4 - 6 and were r and omly assigned to training ( n = 555 ) or validation ( n = 277 ) sets . Multivariate logistic regression analysis revealed that platelet count ( PLT ) , age , AST , and INR were significantly associated with fibrosis . Additional analysis revealed PLT , age , AST , and ALT as an alternative model . Based on this , a simple index ( FIB-4 ) was developed : age ( [ yr ] x AST [ U/L ] ) / ( ( PLT [ 10(9)/L ] ) x ( ALT [U/L])(1/2 ) ) . The AUROC of the index was 0.765 for differentiation between Ishak stage 0 - 3 and 4 - 6 . At a cutoff of < 1.45 in the validation set , the negative predictive value to exclude advanced fibrosis ( stage 4 - 6 ) was 90 % with a sensitivity of 70 % . A cutoff of > 3.25 had a positive predictive value of 65 % and a specificity of 97 % . Using these cutoffs , 87 % of the 198 patients with FIB-4 values outside 1.45 - 3.25 would be correctly classified , and liver biopsy could be avoided in 71 % of the validation group . In conclusion , noninvasive tests can accurately predict hepatic fibrosis and may reduce the need for liver biopsy in the majority of HIV/HCV-coinfected patients BACKGROUND / AIMS Transient elastometry ( TE ) is accurate for detecting cirrhosis ( F=4 ) in human immunodeficiency virus (HIV)/hepatitis C virus ( HCV ) co-infected patients . However , this procedure is less precise to differentiate mild ( F < or = 1 ) from moderate to severe ( F > or = 2 ) fibrosis using the cut-off value of 7.2kPa , a level previously proposed by some authors . Because of this , we elaborated and vali date d cut-off values of liver stiffness ( LS ) to better discriminate F < or = 1 from F > or = 2 in HIV/HCV co-infected subjects to aid therapy decisions . METHODS One hundred and ninety-seven co-infected patients with liver biopsy and TE measurement , without prior therapy against HCV infection , were included . RESULTS To diagnose F < or = 2 , a cut-off of 9.0kPa showed a positive predictive value of 87 % . To discard F > or = 2 , a cut-off of 6.0kPa showed a negative predictive value of 90 % . Considering all the patients , 61 ( 31 % ) patients yielded LS values < or = 6.0kPa and 81 ( 41 % ) patients showed LS values > or = 9.0kPa . There were no severe classification errors as the NPV of L < or = S6.0kPa for F > or = 3 Output:	Transient elastography is a noninvasive imaging modality with excellent ability to assess for cirrhosis in patients with HIV-HCV coinfection
MS2649	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background To answer the question if and to which extent acute symptoms at the end and /or several weeks after radiotherapy can predict adverse urinary and gastrointestinal long-term quality of life ( QoL ) . Methods A group of 298 patients has been surveyed prospect ively before ( time A ) , at the last day ( B ) , two months after ( C ) and > one year after ( D ) radiotherapy using a vali date d question naire ( Exp and ed Prostate Cancer Index Composite ) . A subgroup of 10 % with the greatest urinary/bowel bother score decrease at time D was defined as patients with adverse long-term QoL. Results Subgroup and correlation analyses could demonstrate a strong dependence of urinary/bowel QoL after radiotherapy on urinary/bowel QoL before radiotherapy . In contrast to absolute scores , QoL score changes ( relative to baseline scores ) did not correlate with pretreatment scores . Long-term changes could be well predicted by acute changes . Patients reporting great/moderate bother with urinary/bowel problems at time C reported to have great/moderate bother at time D in ≥ 50 % , respectively . In a multivariate analysis of factors for adverse long-term urinary and bowel QoL , score changes at time C were found to be independent predictors , respectively . Additionally , QoL changes at time B were independently predictive for adverse long-term bowel QoL. Conclusions Consequential late effects play a major role after radiotherapy for prostate cancer . Patients with greater and particularly longer non-healing acute toxicity are c and i date s for closer follow-up and possible prophylactic actions to reduce a high probability of long-term problems PURPOSE To compare the toxicity between hypofractionation vs. conventional fractionation schedules in patients with high-risk prostate cancer . METHODS AND MATERIAL S Between January 2003 and December 2007 , 168 patients were r and omized to receive either hypofractionated ( 62 Gy in 20 fractions within 5 weeks , 4 fractions/wk ) or conventionally fractionated ( 80 Gy in 40 fractions within 8 weeks ) three-dimensional conformal radiotherapy to the prostate and seminal vesicles . All patients had undergone a 9-month course of total and rogen deprivation , with radiotherapy starting 2 months after initiation of the total and rogen deprivation . RESULTS The median follow-up was 32 and 35 months in the hypofractionation and conventional fractionation arms , respectively . For the patients developing acute toxicity , no difference between the two fractionation groups was found in either severity or duration of gastrointestinal or genitourinary toxicity . Also , no difference was found in the incidence and severity of late gastrointestinal and genitourinary toxicity between the two treatment schedules , with a 3-year rate of Grade 2 or greater toxicity of 17 % and 16 % for the hypofractionation arm and 14 % and 11 % for the conventional fractionation arm , respectively . A statistically significant correlation between acute and late gastrointestinal toxicity was found only in the conventional fractionation group . CONCLUSION Our findings suggest that the hypofractionation regimen used in our study is safe , with only a slight , nonsignificant increase in tolerable and temporary acute toxicity compared with the conventional fractionation schedule . The severity and frequency of late complications was equivalent between the two treatment groups PURPOSE To report toxicity and preliminary biochemical outcomes with high-dose intensity-modulated radiation therapy ( IMRT ) to a dose of 86.4 Gy for localized prostate cancer . METHODS AND MATERIAL S Between August 1997 and March 2004 , 478 patients were treated with 86.4 Gy using a 5- to 7-field IMRT technique . To adhere to normal tissue constraints , the mean D95 and V100 for the planning target volume were 83 Gy and 87 % , respectively . Toxicity data were scored according to the Common Terminology Criteria for Adverse Events Version 3.0 . Freedom from biochemical relapse was calculated . The median follow-up was 53 months . RESULTS Thirty-seven patients ( 8 % ) experienced acute Grade 2 gastrointestinal ( GI ) toxicity . There was no acute Grade 3 or 4 GI toxicity . One hundred and five patients ( 22 % ) experienced acute Grade 2 genitourinary ( GU ) toxicity and three patients ( 0.6 % ) had Grade 3 GU toxicity . There was no acute Grade 4 GU toxicity . Sixteen patients ( 3 % ) developed late Grade 2 GI toxicity and two patients ( < 1 % ) developed late Grade 3 GI toxicity . Sixty patients ( 13 % ) had late Grade 2 GU toxicity and 12 ( <3 % ) experienced late Grade 3 GU toxicity . The 5-year actuarial PSA relapse-free survival according to the nadir plus 2 ng/mL definition was 98 % , 85 % and 70 % for the low , intermediate , and high risk NCCN prognostic groups . CONCLUSION This report represents the largest data set of patients treated to ultra-high radiation dose levels of 86.4 Gy using IMRT for localized prostate cancer . Our findings indicate that this treatment is well tolerated and the early excellent biochemical control rates are encouraging Background As dose-escalation in prostate cancer radiotherapy improves cure rates , a major concern is rectal toxicity . We prospect ively assessed an innovative approach of hydrogel injection between prostate and rectum to reduce the radiation dose to the rectum and thus side effects in dose-escalated prostate radiotherapy . Methods Acute toxicity and planning parameters were prospect ively evaluated in patients with T1 - 2 N0 M0 prostate cancer receiving dose-escalated radiotherapy after injection of a hydrogel spacer . Before and after hydrogel injection , we performed MRI scans for anatomical assessment of rectal separation . Radiotherapy was planned and administered to 78 Gy in 39 fractions . Results From eleven patients scheduled for spacer injection the procedure could be performed in ten . In one patient hydrodissection of the Denonvillier space was not possible . Radiation treatment planning showed low rectal doses despite dose-escalation to the target . In accordance with this , acute rectal toxicity was mild without grade 2 events and there was complete resolution within four to twelve weeks . Conclusions This prospect i ve study suggests that hydrogel injection is feasible and may prevent rectal toxicity in dose-escalated radiotherapy of prostate cancer . Further evaluation is necessary including the definition of patients who might benefit from this approach . Trial registration : German Clinical Trials Register DRKS00003273 Objective To determine late toxicity and quality of life ( QoL ) in patients with localized prostate cancer after high-dose intensity-modulated radiotherapy (IMRT).Patient and methods This was a prospect i ve study in patients with localized prostate adenocarcinoma who had been treated by IMRT ( 76 Gy ) between February and November 2006 . Physicians scored acute and late toxicity using the Common Terminology Criteria for Adverse Events ( version 3.0 ) . Patients completed cancer and prostate-specific QoL question naires ( EORTC QLQ-C30 and QLQ-PR25 ) before IMRT ( baseline ) and at 2 , 6 , 18 and 54 months . Result Data were available for 38 patients ( median age , 73 years ) ( 18 % low risk ; 60 % intermediate risk ; 32 % high risk ) . The incidence of urinary and gastrointestinal toxicity was respectively : immediately post IMRT : 36.8 % and 23.7 % ( grade 1 ) , 5.3 % and 5.3 % ( grade 2 ) , 2.6 % and 0 % ( grade 3 ) ; at 18 months : 23.7 % and 10.3 % ( grade 1 ) , 26.3 % and 13.2 % ( grade 2 ) , 0 % and 2.6 % ( grade 3 ) ; at 54 months : 34.2 % and 23.7 % ( grade 1 ) , 5.3 % and 15.8 % ( grade 2 ) , 5.3 % and 0 % ( grade 3 ) . At 54 months , significant worsening was reported by patients for 11/19 QoL items but the worsening was clinical ly relevant ( > 10 points ) for 7 items only : physical , role as well as social functioning , fatigue , pain , dyspnoea and constipation . There was no significant difference between 54-month and baseline QoL scores for global health , gastrointestinal symptoms , treatment-related symptoms and sexual function . However , there was significant - but clinical ly non-relevant ( < 10 points ) - worsening of urinary symptom . Conclusion High-dose IMRT to the prostate with accurate patient positioning did not induce any clinical ly relevant worsening in late urinary and gastrointestinal QoL at 54 months . Impaired physical and role functioning may be related to age and comorbidities Purpose : To assess whether the topical use of steroids or 5-aminosalicylic acid ( 5-ASA ) is superior to sucralfate in preventing acute rectal toxicity during three-dimensional conformal radiotherapy ( 3DCRT ) to 76 Gy . Patients and Methods : Patients undergoing 3DCRT for prostate carcinoma at our institution were offered to be r and omized to sucralfate 3 g in 15 ml suspension enema ( Antepsin ® ) , mesalazine 4 g gel enema ( Enterasyn ® ) , or hydrocortisone 100 mg foam enema ( Colifoam ® ) . R and omization was blind to the treating physician but not to the patient . Sucralfate was chosen as control arm . Topical treatment had to be performed once daily , starting on day 1 of 3DCRT . Acute rectal toxicity was scored weekly according to RTOG criteria . Time to occurrence of grade 2 + acute rectal toxicity was taken as endpoint . Results : The trial was opened in August 1999 , and after the first 24 patients had been treated , arm 2 was discontinued because of eight patients receiving mesalazine , seven actually developed acute rectal toxicity ( five patients grade 3 and two patients grade 2).Until May 2001 , 134 consecutive patients were r and omly assigned to sucralfate ( 63 patients ) , mesalazine ( eight patients ) or hydrocortisone ( 63 patients ) . The cumulative incidence of acute rectal toxicity at the end of treatment by arm is 61.9 ± 6.1 % , 87.5 ± 11.7 % , and 52.4 ± 6.2 % for arms 1 , 2 , and 3 , respectively . The difference between the mesalazine group and the sucralfate group is highly significant ( hazard ratio [ HR ] 2.5 , 95 % confidence interval [ CI ] 1.1–5.7 ; p = 0.03 ) . At both uni- and multivariate analysis taking into account several patients and treatment covariates , the difference between hydrocortisone and sucralfate is not significant ( HR 0.7 , 95 % CI 0.5–1.2 ; p = 0.2 ) . Conclusion : Topical mesalazine is contraindicated during radiotherapy . Hydrocortisone enema is not superior to sucralfate in preventing acute rectal toxicity . Fragestellung : R and omisierter Vergleich der lokalen Anwendung von Steroiden oder 5-ASA oder Sucralfat zur Prävention einer akuten Strahlenproktitis unter 3-D-konformaler Radiotherapie ( 3DCRT ) bis 76 Gy . Patienten und Method ik : Patienten , die sich in unserer Klinik wegen eines Prostatakarzinoms einer 3DCRT unterzogen , wurde r and omisiert angeboten eine Vorbeh and lung 1 ) mit Sucralfat ( 3 g suspendiert i m 15-ml-Klysma ) , 2 ) Mesalazin als 4-g-Gelklysma ) oder 3 ) Hydrocortison : 100 mg als Schaumklysma ) . Die R and omisierung zu einem dieser drei Studienarme war dem beh and elnden Arzt unbekannt , nicht aber dem Patienten . Sucralfat wurde als Kontrollarm gewählt . Die jeweilige topische Therapie musste ab dem 1 . Tag der 3DCRT einmal täglich durchgeführt werden . Auf akute Strahlenproktitis wurde jede Woche nach RTOG-Kriterien geprüft . Als Endpunkt wurde das Auftreten einer akuten Strahlenproktitis Grad 2 festgelegt . Ergebnisse : Die Studie begann i m August 1999 . Nachdem die ersten 24 Patienten aufgenommen worden waren , wurde Arm 2 abgebrochen , da sieben Patienten unter Mesalazin eine akute Strahlenproktitis ( Grad 3 bei fünf Patienten und Grad 2 bei zwei Patienten ) entwickelten . Bis zum Mai 2001 wurden 134 Patienten der lokalen Anwendung von Sucralfat ( 63 Patienten ) , Mesalazin ( acht Patienten ) oder Hydrocortison ( 63 Patienten ) zugeführt . Die kumulative Inzidenz akuter Strahlenproktitis betrug jeweils 61,9 ± 6,1 % , 87,5 ± 11,7 % und 52,4 ± 6,2 % . Der Unterschied zwischen Mesalazin- und Sucralfat-Gruppe ist hoch signifikant ( HR : 2,5 ; Output:	In this systematic review of published reports , we found that late gastrointestinal toxicity following prostate radiotherapy seems to be statistically and potentially causally related to acute gastrointestinal morbidity as a consequential effect . We su bmi t that acute gastrointestinal toxicity may be used to identify at-risk patients who may benefit from additional attention for medical interventions and close follow-up to prevent late toxicity .
MS2650	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE The primary goal of this stratified r and omized controlled trial ( S RCT ) was to compare the stability of dental implants placed under three different loading regimens during the first 16 weeks of healing following implant placement . Implants were loaded immediately , early ( 6 weeks ) , or with conventional/delayed timing ( 12 weeks ) . Secondary outcomes were to compare marginal bone adaptation for 3 years after placement . MATERIAL S AND METHODS Single posterior implant sites in the maxilla or m and ible were examined . The insertion torque value was the primary determinant of load assignment . Resonance frequency analysis was performed at follow-up appointments for the first 16 weeks ( with results provided as implant stability quotients [ ISQs ] ) . Marginal bone levels were assessed via radiographs . RESULTS Forty patients each received a single 4.0-mm diameter dental implant between 2004 and 2007 . One implant failure occurred in Lekholm and Zarb type 4 bone with insertion torque value ( ITV ) of < 8.1 Ncm ; the cumulative success rate was 97.5 % . All implants , when classified by bone and loading type , increased in stability over time , with a minor reduction of 1.3 ISQ units seen at 4 weeks in the immediate loading group . The mean marginal bone loss over 3 years was 0.22 mm . The mean ITVs at implant placement for bone types 1 and 2 ( grouped together ) , 3 , and 4 were 32 , 17 , and 10 , respectively , and were significantly different ( P < .05 ) . CONCLUSIONS ITV was a good objective measure of bone type . Using an ITV of 20 Ncm as the determinant for immediate loading and an ITV of 10 Ncm or greater as the determinant for early loading provided long-term success for this implant and led to no negative changes in tissue response . All bone type groups and loading groups showed no reduction in stability during the first 4 months of healing PURPOSE The possibility of expediting dental implant therapy by early or immediate loading protocol s requires long-term clinical investigation . The aim of this prospect i ve cohort trial was to determine the 3-year implant success rate and prosthesis complications associated with functional loading 3 weeks after 1-stage placement of Astra Tech single-tooth implants replacing maxillary anterior teeth . A secondary objective was to determine peri-implant tissue responses at these implants . MATERIAL S AND METHODS The peri-implant bone and mucosal conditions of 43 implants in 39 subjects were radiographically and clinical ly measured 3 years after implant placement . RESULTS Of the 48 patients originally treated , 39 patients and 43 implants were examined at the 3-year time point . Three of 54 implants failed within the first year . No additional failures were recorded since the 12-month reporting period . Peri-implant bone levels were stable for the 3-year period following implant placement . The change in marginal bone levels after 3 years was 0.42 + /- 0.59 mm . Papilla growth was measured at 1 and 3 years ( 0.61 + /- 0.95 mm and 0.74 + /- 0.79 mm , respectively ) . The buccal peri-implant tissue dimensions at the gingival zenith also increased at 1 and 3 years ( 0.34 + /- 0.94 mm and 0.51 + /- 1.42 mm , respectively ) . No abutment screw loosening or fracture occurred . DISCUSSION AND CONCLUSIONS Early loading of endosseous dental implants placed in healed ridges offers select benefits to clinicians and their patients BACKGROUND Interest in the use of one-stage surgery and immediate loading of oral implants has lately been increasing . PURPOSE The aim of this study was to compare the 3-year results of one-stage surgery versus two-stage surgery , early loading versus loading after a 3-month healing period , and the use of one-piece implants versus the use of two-piece implants . MATERIAL S AND METHODS The study included 108 patients with edentulous m and ibles . Each patient was treated with four Brånemark System implants ( Nobel Biocare AB , Göteborg , Sweden ) and with full fixed prostheses . Patients were consecutively treated and were distributed in four groups : group A ( one-stage surgery ) , group B ( control group with two-stage surgery ) , group C ( one-piece implants ) , and group D ( early loading ) . In groups A and B Brånemark St and ard implants and st and ard abutments were used . In group C the conical one-piece Brånemark implant was used , and in group D the patients had Brånemark System Mk III implants together with multiunit abutments . All patients were observed for 3 years . RESULTS Of the 432 inserted implants , 24 were lost . Survival rates in the three experimental groups ranged from 93.2 to 93.3 % whereas the survival rate in group B ( the control group with two-stage surgery ) was 97.5 % . The differences between the groups were not statistically significant . The changes in marginal bone level were measured from fixture insertion to the final follow-up at 3 years . The bone loss in group D ( early loading ) was significantly less than in group B ( the control group ) whereas there were no differences in marginal bone change between the other groups . CONCLUSIONS Early loading seemed to give good results in the anterior part of the m and ible . The survival rate of the early-loaded implants did not significantly differ from that of implants inserted with the conventional two-stage procedure , but the mean marginal bone loss around the surviving implants was less with early loading AIM To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 3-year , parallel group , r and omized clinical trial . MATERIAL S AND METHODS The study was conducted in a private dental clinic between July 2005 and July 2010 . Patients 18 years or older were r and omized to receive implants for fixed partial dentures in cases of partial edentulism . The test group was represented by immediate non-occlusal implant loading , whereas the control group was represented by early non-occlusal implant loading . The outcome variables were implant failure , complications and radiographic bone level at implant sites 3 years after loading , measured from the implant-abutment junction to the most coronal point of bone-to-implant contact . R and omization was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes , and the measurer was blinded to group assignment . RESULTS Sixty patients were r and omized : 30 to the immediately loaded group and 30 to the early loaded group . Four patients dropped out ; however , the data of all patients were included in the analysis . No implant failure occurred . Two complications occurred in the control group and one in the test group . The mean bone level at 3 years was 1.91 mm for test group and 1.59 mm for control group . The adjusted difference in bone level was 0.26 mm ( CI 95 % -0.08 to 0.59 , p = 0.1232 ) . CONCLUSION The null hypothesis of no difference in failure rates , complications and bone level between implants that were loaded immediately or early at 3 years can not be rejected in this r and omized clinical trial PURPOSE To evaluate the medium-term effectiveness of 6.5 mm-long flapless-placed single implants immediately or early loaded at 6 weeks . MATERIAL S AND METHODS Thirty patients received two single NanoTite external hex Biomet 3i implants each , which were then r and omly allocated to be immediately or early loaded according to a splitmouth design . Implants had to be inserted with a minimum torque of > 40 Ncm . Provisional crowns were put in slight occlusal contact and replaced by definitive crowns 3 months after loading . Patients were followed for 4 years after loading . Outcome measures were implant failures , biological and biomechanical complications , peri-implant marginal bone level changes , and patient preference . RESULTS Twenty-nine implants were immediately loaded and 31 early loaded . Four years after loading , no drop-outs occurred . One implant failed in each group within 2 months after loading . Seven patients experienced complications at immediately loaded implants and 6 at early loaded implants . There were no statistically significant differences between groups for implant losses , complications , mean marginal bone level changes and patient preference . CONCLUSIONS Flapless-placed 6.5 mm-long single implants can be immediately loaded and remain successful up to 4 years after loading . Even longer follow-ups are still needed to evaluate the longterm prognosis of short implants PURPOSE To evaluate the efficacy of 7-mm-long flapless placed single implants immediately or early loaded at 6 weeks . MATERIAL S AND METHODS Thirty patients received two single Nanotite External Hex Biomet 3i implants that were then r and omised for immediate or early loading . All implants had to be inserted with a minimum torque > 40Ncm . Provisional crowns were put in slight occlusal contact and replaced by definitive crowns 3 months after loading . Outcome measures were implant failures , biological and biomechanical complications , peri-implant marginal bone level changes and patient preference . RESULTS Twenty-nine implants were immediately loaded and 31 early loaded . Thirteen flaps had to be elevated in 12 patients . Eleven implants in ten patients did not reach the planned insertion torque . Eight implants in seven patients were immediately replaced by implants with a larger diameter , two were loaded anyway , and one implant that was r and omised to immediate loading was early loaded instead . Nine months after loading , no drop-out occurred . One implant failed in each group . There were no statistically significant differences between groups for implant losses , complications , mean marginal bone level changes , and patient preferences . CONCLUSIONS Flapless placed 7-mm-long single implants can be successfully loaded the day of insertion . Longer follow-ups are needed to monitor the long-term prognosis of short implants In this study , 19 patients were treated with 36 Brånemark System MK III TiUnite implants in the maxilla . Definitive implant-supported single crowns were delivered to patients 6 weeks after implant placement . Clinical and radiographic parameters were recorded at baseline , and at 1 , 2 , and 3 years . Both implant and prosthesis success rates were 94 % after 3 years . The average marginal bone loss was 0.97 mm after 3 years . The results of this study indicate that 6-week early loading of TiUnite surface implants in the maxilla was reliable and predictable for this patient population and may offer an alternative to the st and ard loading protocol PURPOSE This study evaluated the survival parameters of single-tooth implants through clinical and radiographic analysis . MATERIAL S AND METHODS Implants were restored within a 24-hour period with a provisional crown design ed to receive an occlusal masticatory load . This approach was compared to implants restored after a healing period ( the control group ) . Forty-six implants were placed in 23 patients who were each treated with 2 Frialit-2 implants placed in sites between the second premolar in the maxilla or m and ible . The manufacturer 's recommended formal surgical procedure was followed , and primary stability was st and ardized with a minimum insertion torque of 20 Ncm . The sites were r and omly selected , and the clinical and radiographic parameters were st and ardized with individual templates . RESULTS Data were collected at 24 h , and at 1 , 3 , 6 , 12 , 18 , and 24 months . The experimental group included 10 failed implants ; 9 of the failed implants had been placed with an insertion torque of 20 Ncm . One implant from the control group failed during the 24-month follow-up period . The survival rate was independent of implant length , site position , and bone quality and quantity . Relative risk for implant failure was associated with insertion torque ( relative risk 0.79 [ CI : 0.66 - 0.930 ] ; Cox regression ) ( P < or = .007 ) , in the experimental group but was not significant for those in the control group ( ie , implants placed after a healing period ; relative risk 0.78 [ CI : 0.34 - 1.78 ] ; Cox regression ) ( P < or = .057 ) . To achieve osseointegration , it was found that an insertion torque above 32 Ncm was necessary ( chi2= 15.68 ; P < or = .004 ) . DISCUSSION A careful evaluation is necessary for a better underst and ing of the survival rates of immediately loaded implants . In this study , insertion torque was associated with the potential for risk , which can be decreased by 20 % per 9.8 Ncm added . CONCLUSION Given these results , and considering the number of patients treated , immediate provisional crowns should only be proposed with early loading if an appropriate initial insertion torque has been applied PURPOSE The aim of this report is to present the implant and clinical outcomes of an immediate-loading protocol of TiUnite implants with m and ibular overdentures in edentulous patients . MATERIAL S AND METHODS Two groups of edentulous patients were selected . Thirty-five consecutively treated patients received 70 immediately loaded TiUnite implants and 69 Brånemark implants as backup ( 1 patient received 1 Brånemark implant ) . The control group was a historical cohort that comprised 42 patients who received 111 Brånemark implants . All overdentures were supported by a resilient bar mechanism . Implant and clinical outcomes , including maintenance events for the first year , were recorded . RESULTS Implant success rates were in excess of 95 % with both protocol s. Immediately loaded implants had less bone loss than did implants loaded with the conventional protocol ( Mann-Whitney U test ; P = Output:	This systematic review showed no significant differences between early and immediate loading protocol s in single implant crowns with regard to survival rate or marginal bone loss at 1 or 3 years
MS2651	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: CONTEXT The association between environmental tobacco smoke ( ETS ) exposure and respiratory symptoms has not been well established in adults . OBJECTIVE To study the respiratory health of bartenders before and after legislative prohibition of smoking in all bars and taverns by the state of California . DESIGN Cohort of bartenders interviewed before and after smoking prohibition . SETTING AND PARTICIPANTS Bartenders at a r and om sample of bars and taverns in San Francisco . MAIN OUTCOME MEASURES Interviews assessed respiratory symptoms , sensory irritation symptoms , ETS exposure , personal smoking , and recent upper respiratory tract infections . Spirometric assessment included forced expiratory volume in 1 second ( FEV1 ) and forced vital capacity ( FVC ) measurements . RESULTS Fifty-three of 67 eligible bartenders were interviewed . At baseline , all 53 bartenders reported workplace ETS exposure . After the smoking ban , self-reported ETS exposure at work declined from a median of 28 to 2 hours per week ( P<.001 ) . Thirty-nine bartenders ( 74 % ) initially reported respiratory symptoms . Of those symptomatic at baseline , 23 ( 59 % ) no longer had symptoms at follow-up ( P<.001 ) . Forty-one bartenders ( 77 % ) initially reported sensory irritation symptoms . At follow-up , 32 ( 78 % ) of these subjects had resolution of symptoms ( P<.001 ) . After prohibition of workplace smoking , we observed improvement in mean FVC ( 0.189 L ; 95 % confidence interval [ CI ] , 0.082 - 0.296 L ; 4.2 % change ) and , to a lesser extent , mean FEV1 ( 0.039 L ; 95 % CI , -0.030 to 0.107 L ; 1.2 % change ) . Complete cessation of workplace ETS exposure ( compared with continued exposure ) was associated with improved mean FVC ( 0.287 L ; 95 % CI , 0.088 - 0.486 ; 6.8 % change ) and mean FEV1 ( 0.142 L ; 95 % CI , 0.020 - 0.264 L ; 4.5 % change ) , after controlling for personal smoking and recent upper respiratory tract infections . CONCLUSION Establishment of smoke-free bars and taverns was associated with a rapid improvement of respiratory health Smoking and health are increasingly understood to be incompatible . To evaluate , prospect ively and retrospectively , the attitudes of employees , staff physicians , and patients of a medical institution , a question naire was administered before and after implementation of a no-smoking policy . Of many questions , select ones review ed here focused on the following concerns : ( 1 ) how tobacco smoke affects employees and patients , ( 2 ) employee acceptance of a no-smoking policy before and after its implementation , and ( 3 ) the consequences of the policy on employee smokers . Open-ended questions about smoking were constructed by a committee comprised of clinicians , investigators , and administrators . The question naire was given to 2,000 r and omly selected patients and the institution 's entire staff of 4,200 employees and 225 staff physicians . Data were obtained on three occasions : six months before , six months after , and one year after the implementation of the no-smoking policy . The majority of patients , employees , and physicians indicated that the smoke of others bothered them and ranked the following as most offensive : smell , eye irritation , provocation of sinus problems , coughing , and headache . Approximately 80 percent of employees and patients favored the policy before its inception ; and employees increasingly favored it through the year after its implementation with a favorable attitude increasing by nearly 10 percentage points . One year after implementation , 80 percent of patients were in favor of the policy . In the final survey , 74 percent of respondents indicated the policy had helped them . One year after policy implementation , employee smoking was reduced significantly from 22 to 14 percent ; and of those employees who continued to smoke , 81 percent smoked less than eight cigarettes per day . ( ABSTRACT TRUNCATED AT 250 WORDS In view of the fact that the impact of statewide smoking laws on private worksite policies and the smoking behavior of employees has not been evaluated , two cross-sectional surveys were performed in Vermont to measure compliance with such a law : a r and om-digit telephone survey of employees and a subsequent mail survey of their employers . Employers were not aware that one of their employees had been surveyed . Roughly half ( 56 percent ) of the employees and 66.5 percent of their employers described policies that are in compliance . Among all employers who described policies in compliance with the law , 68.1 percent of their employees also described compliant policies . Among all employees who described non-compliant policies , 48.8 percent had employers who described compliant policies . Overall , employees and employers agreed on how their policies stood with respect to compliance in 67.6 percent of cases . The prevalence and amount of smoking at work declined after the institution of the law but so did the prevalence and amount of smoking at home . Changes toward more restrictive policies were associated with reductions in cigarette consumption at work , but not with quitting . The study suggests that a large fraction of worksite smoking policies may not comply with a statewide worksite smoking law . The proportion of companies complying with such a law may be overestimated if information on compliance is obtained only from employers BACKGROUND AND OBJECTIVES To examine the long term impact of workplace smoking bans on employee smoking cessation and relapse . Over three years we studied a total of 1033 current or former smokers ( intervention group ) employed in smoke-free hospitals and 816 current or former smokers ( comparison group ) employed in non-smoke-free workplaces . The design of this natural experiment is a prospect i ve cohort study . We r and omly selected both hospitals and employees from 12 strata based on hospital size and state tobacco regulations , and sample d employees in the same communities . Main outcome measures were post-ban quit ratio and relapse rate . RESEARCH DESIGN Between groups comparisons were conducted using the Cochran-Mantel-Haenszel statistic for general association , stratified Cox proportional hazards models , and the CMH analysis of variance statistic based on ranks . McNemar 's test and the sign test were used to test for changes over time within each group . RESULTS Differences in the post-ban quit ratio were observed between intervention and comparison groups ( p ⩽ 0.02 ) . For employees whose bans were implemented at least seven years before survey , the post-ban quit ratio was estimated at 0.256 , compared with 0.142 for employees in non-smoke-free workplaces ( p = 0.02 ) . After controlling for a variety of factors , time to quit smoking was shorter for the hospital employees ( p < 0.001 ) , with an overall relative risk of quitting of 2.3 . Contrary to expectations , relapse rates were similar between the groups . CONCLUSION Employees in workplaces with smoking bans have higher rates of smoking cessation than employees where smoking is permitted , but relapse is similar between these two groups of employees . The results of this investigation have international applicability for policy makers , clinicians , employers , and employees . Countries should review smoking policies in workplaces in light of their own smoking patterns and efforts to deal with environmental tobacco smoke STUDY OBJECTIVE : The aim of this study was to evaluate the impact of a smoke free programme implemented at the University of Geneva , Switzerl and , in 1996 . This programme included a prohibition to smoke in university buildings everywhere except in limited areas , and a smoking cessation counselling service . METHODS : Surveys were conducted before and four months after the programme was implemented , in representative sample s of programme participants ( n = 833 ) and university members not exposed to the programme ( n = 1023 ) . RESULTS : In retrospective assessment s , participants reported being less bothered by environmental tobacco smoke after programme implementation , but no between group difference was detected in prospect i ve assessment s. Relationships between smokers and non-smokers improved moderately in the intervention group and remained unchanged in the comparison group ( between group p = 0.001 ) . Proportions of smokers who attempted to quit smoking in the past four months increased from 2.0 % to 3.8 % in the intervention group and remained unchanged at 3.5 % in the comparison group ( between group difference : p = 0.048 ) . No impact on smoking prevalence ( 25 % ) was detected . The programme was appreciated by university members , although some of its modalities were criticised . CONCLUSION : A regulation prohibiting smoking everywhere but in limited areas of university buildings was acceptable and reduced the perception of bother by environmental tobacco smoke . It did not , however , influence smoking habits or attitudes toward smoking Purpose . To determine the prevalence of tobacco use among Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and Disease Registry ( ATSDR ) employees and the effect of the smoke-free policy on smoking behavior and air quality at work . Design . A stratified telephone survey of 1181 CDC/ATSDR employees r and omly selected from employee rosters . Setting . CDC/ATSDR work sites in Atlanta , Georgia , and other major CDC locations throughout the United States and Puerto Rico . Subjects . R and omly selected employees of CDC/ATSDR1 , or about 22 % of the total CDC/ATSDR population ; 98 % of eligible persons selected agreed to participate . Measures . Demographic and smoking history variables , attitudes toward and impact of the smoke-free policy on smoking behavior , and self-report changes in air quality were the measures used . Results . Overall cigarette smoking prevalence was only 11.1 % . One percent reported using chewing tobacco , 1.1 % reported smoking a pipe , and 1.4 % reported smoking cigars . Average self-reported , daily cigarette comsumption significantly decreased after the smoking ban took effect . Overall , 90 % of the employees supported the smoke-free policy , and 80 % of the employees believed that smokers were complying with the smoke-free policy . Most employees believed that the air quality of work areas and nonwork areas ( 65 % and 69 % , respectively ) had improved since the smoke-free policy was implemented . Conclusions . These findings are consistent with previous evaluations of smoke-free policies and suggest that most employees are generally supportive of workplace smoking restrictions . Such policies can also have a positive impact on smoking behavior and perceived air quality BACKGROUND This study reports the barriers and challenges for hospital tobacco control efforts after the institution of smoke-free policies . METHODS Surveys of employees and in patients of five hospitals in Augusta , Georgia , were conducted and evaluated 4 months after joint hospital implementation of smoke-free policies . A r and om sample of 1997 employees and a convenience sample of 517 in patients returned usable surveys . RESULTS Although attitudes to the hospital bans on smoking reflected strong support for smoke-free policies , four out of five hospitals reported significant implementation problems . Despite the bans , 49 % of patients who were smokers continued to smoke while hospitalized , and almost one half of all hospitalized smokers had received no advice to quit smoking from a physician or a nurse since admission . Employees and patients both agreed that the smoke-free policies had benefited employees more than patients . CONCLUSIONS Despite achieving a smoke-free status , there are many challenges that remain for comprehensive hospital tobacco-control efforts . Hospitals and health care professionals must remain particularly alert and attentive to the needs of patients and employees still addicted to tobacco OBJECTIVES This study evaluated the biological and subjective consequences observed in individual smokers after implementation of a workplace smoking-restriction policy . METHODS Employees were evaluated for 4 weeks before and 4 weeks after their workplace became smoke-free ( n = 34 ) . A comparison group of smokers whose work-site smoking was unrestricted served as controls ( n = 33 ) . Daily exposure to tobacco constituents and withdrawal effects were measured . RESULTS Smokers at the restricted site had verified smoking reduction ( mean = four cigarettes per day ) and significantly reduced nicotine and carbon monoxide during the work shift . There were increases in ratings of some common withdrawal symptoms ( cravings/urges , concentration difficulties , increased eating , depression ) . No evidence of compensatory smoking during nonwork hours was found . Overall tobacco exposure , as measured in saliva cotinine , showed a nonsignificant 15 % decline . CONCLUSIONS Workplace smoking restriction markedly altered smoking patterns ( i.e. , reduced daytime smoking ) and reduced cotinine levels to an amount consistent with cigarette reduction . Thus , work-site smoking restriction may promote meaningful , albeit limited , reductions in tobacco exposure and consequent health risks OBJECTIVE To determine the effectiveness of laws restricting youth access to cigarettes on prevalence of smoking among teens . METHODS We conducted a systematic review of studies that reported changes in smoking associated with the presence of restrictions on the ability of teens to purchase cigarettes . We calculated the correlation between merchant compliance levels with youth access laws and prevalence ( 30-day and regular ) prevalence of youth smoking , and between changes in compliance and prevalence associated with youth access interventions . We also conducted a r and om effects meta- analysis to determine the change in youth prevalence associated with youth access interventions from studies that included control communities . RESULTS Based on data from 9 studies , there was no detectable relationship between the level of merchant compliance and 30-day ( r = .116 ; n = 38 communities ) or regular ( r = .017 ) smoking prevalence . There was no evidence of a threshold effect . There was no evidence that an increase Output:	Smoke-free workplaces not only protect non-smokers from the dangers of passive smoking , they also encourage smokers to quit or to reduce consumption
MS2652	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The likelihood of distant recurrence in patients with breast cancer who have no involved lymph nodes and estrogen-receptor-positive tumors is poorly defined by clinical and histopathological measures . METHODS We tested whether the results of a reverse-transcriptase-polymerase-chain-reaction ( RT-PCR ) assay of 21 prospect ively selected genes in paraffin-embedded tumor tissue would correlate with the likelihood of distant recurrence in patients with node-negative , tamoxifen-treated breast cancer who were enrolled in the National Surgical Adjuvant Breast and Bowel Project clinical trial B-14 . The levels of expression of 16 cancer-related genes and 5 reference genes were used in a prospect ively defined algorithm to calculate a recurrence score and to determine a risk group ( low , intermediate , or high ) for each patient . RESULTS Adequate RT-PCR profiles were obtained in 668 of 675 tumor blocks . The proportions of patients categorized as having a low , intermediate , or high risk by the RT-PCR assay were 51 , 22 , and 27 percent , respectively . The Kaplan-Meier estimates of the rates of distant recurrence at 10 years in the low-risk , intermediate-risk , and high-risk groups were 6.8 percent ( 95 percent confidence interval , 4.0 to 9.6 ) , 14.3 percent ( 95 percent confidence interval , 8.3 to 20.3 ) , and 30.5 percent ( 95 percent confidence interval , 23.6 to 37.4 ) . The rate in the low-risk group was significantly lower than that in the high-risk group ( P<0.001 ) . In a multivariate Cox model , the recurrence score provided significant predictive power that was independent of age and tumor size ( P<0.001 ) . The recurrence score was also predictive of overall survival ( P<0.001 ) and could be used as a continuous function to predict distant recurrence in individual patients . CONCLUSIONS The recurrence score has been vali date d as quantifying the likelihood of distant recurrence in tamoxifen-treated patients with node-negative , estrogen-receptor-positive breast cancer PURPOSE Biomarkers can add substantial value to current medical practice by providing an integrated approach to prediction using the genetic makeup of the tumor and the genotype of the patient to guide patient-specific treatment selection . We discuss and evaluate various clinical trial design s for the validation of biomarker-guided therapy . METHODS Design s for predictive marker validation are broadly classified as retrospective ( ie , using data from previously well-conducted r and omized controlled trials [ RCTs ] ) versus prospect i ve ( enrichment , unselected , hybrid , or adaptive analysis ) . We discuss the salient features of each design in the context of real trials . RESULTS Well- design ed retrospective analysis from well-conducted prospect i ve RCTs can bring forward effective treatments to marker-defined subgroups of patients in a timely manner ( eg , KRAS and colorectal cancer ) . Enrichment design s are appropriate when preliminary evidence suggest that patients with or without that marker profile do not benefit from the treatments in question ; however , this may sometimes leave questions unanswered ( eg , trastuzumab and breast cancer ) . An unselected design is optimal where preliminary evidence regarding treatment benefit and assay reproducibility is uncertain ( eg , epidermal growth factor receptor and lung cancer ) . Hybrid design s are appropriate when preliminary evidence demonstrate the efficacy of certain treatments for a marker-defined subgroup , making it unethical to r and omly assign patients with that marker status to other treatments ( eg , multigene assay and breast cancer ) . Adaptive analysis design s allow for prespecified marker-defined subgroup analyses of data from an RCT . CONCLUSION The implementation of these design strategies will lead to a more rapid clinical validation of biomarker-guided therapy PURPOSE Development of a radiosensitivity predictive assay is a central goal of radiation oncology . We reasoned a gene expression model could be developed to predict intrinsic radiosensitivity and treatment response in patients . METHODS AND MATERIAL S Radiosensitivity ( determined by survival fraction at 2 Gy ) was modeled as a function of gene expression , tissue of origin , ras status ( mut/wt ) , and p53 status ( mut/wt ) in 48 human cancer cell lines . Ten genes were identified and used to build a rank-based linear regression algorithm to predict an intrinsic radiosensitivity index ( RSI , high index = radioresistance ) . This model was applied to three independent cohorts treated with concurrent chemoradiation : head- and -neck cancer ( HNC , n = 92 ) ; rectal cancer ( n = 14 ) ; and esophageal cancer ( n = 12 ) . RESULTS Predicted RSI was significantly different in responders ( R ) vs. nonresponders ( NR ) in the rectal ( RSI R vs. NR 0.32 vs. 0.46 , p = 0.03 ) , esophageal ( RSI R vs. NR 0.37 vs. 0.50 , p = 0.05 ) and combined rectal/esophageal ( RSI R vs. NR 0.34 vs. 0.48 , p = 0.001511 ) cohorts . Using a threshold RSI of 0.46 , the model has a sensitivity of 80 % , specificity of 82 % , and positive predictive value of 86 % . Finally , we evaluated the model as a prognostic marker in HNC . There was an improved 2-year locoregional control ( LRC ) in the predicted radiosensitive group ( 2-year LRC 86 % vs. 61 % , p = 0.05 ) . CONCLUSIONS We vali date a robust multigene expression model of intrinsic tumor radiosensitivity in three independent cohorts totaling 118 patients . To our knowledge , this is the first time that a systems biology-based radiosensitivity model is vali date d in multiple independent clinical data sets Predictive biomarkers to guide therapy for cancer patients are a cornerstone of precision medicine . Discussed herein are considerations regarding the design and interpretation of such predictive biomarker studies . These considerations are important for both planning and interpreting prospect i ve studies and for using specimens collected from completed r and omized clinical trials . Specific issues addressed are differentiation between qualitative and quantitative predictive effects , challenges due to sample size requirements for predictive biomarker assessment , and consideration of additional factors relevant to clinical utility assessment , such as toxicity and cost of new therapies as well as costs and potential morbidities associated with routine use of biomarker-based tests The 70-gene signature ( MammaPrint ™ ) has been developed to predict the risk of distant metastases in breast cancer and select those patients who may benefit from adjuvant treatment . Given the strong association between locoregional and distant recurrence , we hypothesize that the 70-gene signature will also be able to predict the risk of locoregional recurrence ( LRR ) . 1,053 breast cancer patients primarily treated with breast-conserving treatment or mastectomy at the Netherl and s Cancer Institute between 1984 and 2006 were included . Adjuvant treatment consisted of radiotherapy , chemotherapy , and /or endocrine therapy as indicated by guidelines used at the time . All patients were included in various 70-gene signature validation studies . After a median follow-up of 8.96 years with 87 LRRs , patients with a high-risk 70-gene signature ( n = 492 ) had an LRR risk of 12.6 % ( 95 % CI 9.7–15.8 ) at 10 years , compared to 6.1 % ( 95 % CI 4.1–8.5 ) for low-risk patients ( n = 561 ; P < 0.001 ) . Adjusting the 70-gene signature in a competing risk model for the clinicopathological factors such as age , tumour size , grade , hormone receptor status , LVI , axillary lymph node involvement , surgical treatment , endocrine treatment , and chemotherapy result ed in a multivariable HR of 1.73 ( 95 % CI 1.02–2.93 ; P = 0.042 ) . Adding the signature to the model based on clinicopathological factors improved the discrimination , albeit non-significantly [ C-index through 10 years changed from 0.731 ( 95 % CI 0.682–0.782 ) to 0.741 ( 95 % CI 0.693–0.790 ) ] . Calibration of the prognostic models was excellent . The 70-gene signature is an independent prognostic factor for LRR . A significantly lower local recurrence risk was seen in patients with a low-risk 70-gene signature compared to those with high-risk 70-gene signature Radical radiotherapy and surgery achieve similar cure rates in muscle-invasive bladder cancer , but the choice of which treatment would be most beneficial can not currently be predicted for individual patients . The primary aim of this study was to assess whether expression of any of a panel of DNA damage signaling proteins in tumor sample s taken before irradiation could be used as a predictive marker of radiotherapy response , or rather was prognostic . Protein expression of MRE11 , RAD50 , NBS1 , ATM , and H2AX was studied by immunohistochemistry in pretreatment tumor specimens from two cohorts of bladder cancer patients ( validation cohort prospect ively acquired ) treated with radical radiotherapy and one cohort of cystectomy patients . In the radiotherapy test cohort ( n = 86 ) , low tumor MRE11 expression was associated with worse cancer-specific survival compared with high expression [ 43.1 % versus 68.7 % 3-year cause-specific survival ( CSS ) , P = 0.012 ] by Kaplan-Meier analysis . This was confirmed in the radiotherapy validation cohort ( n = 93 ; 43.0 % versus 71.2 % , P = 0.020 ) . However , in the cystectomy cohort ( n = 88 ) , MRE11 expression was not associated with cancer-specific survival , commensurate with MRE11 being a predictive marker . High MRE11 expression in the combined radiotherapy cohort had a significantly better cancer-specific survival compared with the high-expression cystectomy cohort ( 69.9 % versus 53.8 % 3-year CSS , P = 0.021 ) . In this vali date d immunohistochemistry study , MRE11 protein expression was shown and confirmed as a predictive factor associated with survival following bladder cancer radiotherapy , justifying its inclusion in subsequent trial design s. MRE11 expression may ultimately allow patient selection for radiotherapy or cystectomy , thus improving overall cure rates BACKGROUND The efficacy of the ALK inhibitor crizotinib as compared with st and ard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer ( NSCLC ) is unknown . METHODS We conducted an open-label , phase 3 trial comparing crizotinib with chemotherapy in 343 patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease . Patients were r and omly assigned to receive oral crizotinib at a dose of 250 mg twice daily or to receive intravenous chemotherapy ( pemetrexed , 500 mg per square meter of body-surface area , plus either cisplatin , 75 mg per square meter , or carboplatin , target area under the curve of 5 to 6 mg per milliliter per minute ) every 3 weeks for up to six cycles . Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy . The primary end point was progression-free survival as assessed by independent radiologic review . RESULTS Progression-free survival was significantly longer with crizotinib than with chemotherapy ( median , 10.9 months vs. 7.0 months ; hazard ratio for progression or death with crizotinib , 0.45 ; 95 % confidence interval [ CI ] , 0.35 to 0.60 ; P<0.001 ) . Objective response rates were 74 % and 45 % , respectively ( P<0.001 ) . Median overall survival was not reached in either group ( hazard ratio for death with crizotinib , 0.82 ; 95 % CI , 0.54 to 1.26 ; P=0.36 ) ; the probability of 1-year survival was 84 % with crizotinib and 79 % with chemotherapy . The most common adverse events with crizotinib were vision disorders , diarrhea , nausea , and edema , and the most common events with chemotherapy were nausea , fatigue , vomiting , and decreased appetite . As compared with chemotherapy , crizotinib was associated with greater reduction in lung cancer symptoms and greater improvement in quality of life . CONCLUSIONS Crizotinib was superior to st and ard first-line pemetrexed-plus-platinum chemotherapy in patients with previously untreated advanced ALK-positive NSCLC . ( Funded by Pfizer ; PROFILE 1014 Clinical Trials.gov number , NCT01154140 . ) PURPOSE To investigate the expression and predictive role of the Mre11/Rad50/Nbs1 ( MRN ) complex and the ataxia-telangiectasia mutated protein ( ATM ) for the outcome of radiotherapy in breast cancer patients . METHODS AND MATERIAL S The protein expression of ATM and the DNA repair proteins in the MRN complex were investigated using immunoh Output:	Although these biomarkers show promise , there is not enough evidence to justify their use in routine practice .
MS2653	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Spasm through the internal anal sphincter is one of the supposed causes for pain after hemorrhoidectomy , a common and distressing experience . We hypothesized that the addition of topical nifedipine to lidocaine would improve pain control by causing a relaxation of the smooth muscle of the internal anal sphincter . METHODS We conducted a multicentre r and omized , double-blind trial to compare the efficacy of 0.3 % nifedipine and 1.5 % lidocaine ointment versus 1.5 % lidocaine ointment alone in reducing pain after hemorrhoidectomy . A physician unaware of the treatment arm measured pain by use of the Analogue Chromatic Continuous Scale ( ACCS ) at baseline ; soon after surgery ; at 2 , 4 , 6 , 8 and 24 hours after surgery ; on day 7 after surgery ; and at a final visit 14 days after surgery . The physician also noted the time to first analgesic administration within 24 hours after surgery . RESULTS In all , 135 patients per group participated ( 270 total ) . Evaluation of the delta ACCS score versus basal value , a covariate for rescue analgesic administration time , revealed better pain control in the group that received nifedipine with lidocaine at 6 hours after surgery and on day 7 ( p < 0.011 and p < 0.054 , respectively ) . We noticed no difference between groups for time of administration of rescue analgesic , blood pressure , heart rate or frequency of headache . CONCLUSION Although there was no difference between groups for time of administration of rescue analgesic after open hemorrhoidectomy , the patients ' assessment of pain using ACCS showed that the use of topical nifedipine with lidocaine may provide a slight significant difference in favour of the study group at 6 hours and at day 7 after surgery . Narcotic analgesics and nonsteroidal anti-inflammatory drug administration should continue to be recommended . Further research focusing on these outcomes is warranted Background Milligan-Morgan excision haem-orrhoidectomy remains a very popular treatment modality for third and fourth degree haemorrhoids due to its cost effectiveness and good long-term results . The LigaSure tissue-sealing device is an alternative technique used in haemorrhoidectomy that has been shown to produce favourable results . The aim of this study was to assess the effectiveness of the LigaSure tissue sealing device in comparison with conventional diathermy haemorrhoidectomy Methods A prospect i ve clinical trial was conducted . Patients with newly diagnosed haemorrhoids requiring haemorrhoidectomy were r and omized to either LigaSure haemorrhoidectomy or diathermy haemorrhoidectomy . Surgical technique and postoperative care was st and ardized . Outcome measures were operative time and bleeding , postoperative pain ( measured on a visual analogue scale ) and rate of wound healing Results We r and omized 44 patients , 22 to LigaSure and 22 to diathermy ; 43 patients were evaluated . They were aged between 19 and 71 years . There were no differences in patient demographics or type of haemorrhoid being operated on . LigaSure haemorrhoidectomy had a significantly lower mean operative time and intraoperative bleeding . At 3 weeks after surgery , haemorrhoidectomy performed with LigaSure had an odds ratio for complete epithelialization of 3.1 over diathermy ( 95 % CI 1.2–8.2 ) . There was no difference in postoperative pain Conclusion LigaSure haemorrhoidectomy is superior to diathermy for open Objective To determine whether a combination of topical anesthetic ( EMLA ) and local injection with lidocaine is better than lidocaine alone for pain relief after Ferguson hemorrhoidectomy . Methods Sixty patients scheduled for hemorrhoidectomy were r and omized into 2 groups : ( 1 ) control group ( CG , n=30 ) received neomycin ointment ( 5 g ) , and ( 2 ) EMLA group ( EG , n=30 ) received EMLA ( 5 g ) , both agents applied topically after surgery . Before the surgical incision was made , lidocaine ( 10 mL of a 1 % solution ) was locally injected into all 60 patients . After surgery , analgesics were provided when necessary . The visual analog scale score was recorded at 4 time points : ( 1 ) upon arrival in the postanesthesia room , ( 2 ) 2 hours after arriving in the postanesthesia room , ( 3 ) between 9 and 10 PM on the first postoperative evening , and ( 4 ) on the first postoperative morning . The frequency of meperidine requests , 1-time catheterizations for urinary retention , and patient satisfaction with postoperative pain management , were also recorded . Results The median visual analog scale scores and cumulative dosages of meperidine were significantly lower in the EG than the CG ( P<0.05 ) . Patient satisfaction with postoperative pain control was also significantly higher in the EG than the CG ( P<0.01 ) . No systemic complications occurred . Discussion EMLA is considered a breakthrough in cutaneous analgesia , capable of reducing pain in many cutaneous procedures . Because Ferguson hemorrhoidectomy has been performed for years with ongoing concerns over postoperative pain , we felt that using EMLA could lower postoperative pain intensity and the number of requests for additional medication Purpose We compared the efficacy and side effects of diclofenac and a topical eutectic mixture of local anesthetics ( EMLA ) for pain relief after hemorrhoidectomy . Methods Ninety patients , nominated for elective hemorrhoidectomy , were recruited for this r and omized clinical trial and were r and omly categorized into three groups ( 30 patients in each group ) . After surgery , the patients in the first group received one 100 mg diclofenac suppository , those in the second group received 5 g of EMLA , and those in the third group received 5 g of petrolatum ointment ( control group ) . The pain intensity was measured using a visual analog scale ( VAS ) . Twenty-five mg of intramuscular pethidine was administered upon the patient ’s request . Pain measurements were performed on the patient ’s transfer to the recovery ward , 2 h after surgery , the evening and the morning after surgery . Results The EMLA group yielded the lowest VAS score on transfer to recovery and at 2 h after surgery ( p < 0.05 ) . The diclofenac group reported the lowest VAS score in the evening and the morning after surgery ( p < 0.05 ) . Conclusions Topical use of an EMLA cream is appropriate for short-term pain control following hemorrhoidectomy , while diclofenac yields a more sustainable pain control OBJECTIVES Control of postoperative symptoms is of paramount importance in proctologic surgery . Phlebotropic activity , protective effect on the capillaries and anti-inflammatory properties of the flavonoids have been reported in several studies . They have been used to treat a variety of conditions including chronic venous insufficiency , lymphedema and hemorrhoids . Numerous trials , assessing the effect of phlebotonics in treating the symptoms and signs of haemorrhoidal disease , suggest that there is a potential benefit . Our trial was conducted to evaluate whether the flavonoids reduce postoperative bleeding , pain and other symptoms after hemorrhoidectomy . PATIENTS AND METHODS We compared the results obtained in 24 patients undergoing open hemorrhoidectomy with radiofrequency scalpel . Our study cohort was r and omized in two groups : the Group A received flavonoids in the postoperative period , the Group B has constituted the control group , without administration of study drug . Follow-up outpatient visits were performed on 7 , 15 and 30 postoperative day ( POD ) . During the visits the patients expressed trough a list of specific questions , based on a scoring system ( 1 to 10 ) , their opi-nion about the extent of postoperative symptoms as pain , bleeding , tenesmus , pruritus and perianal weight . RESULTS We observed that the results obtained after 7 days of surgery are similar in both study groups . Even after 15 and 30 days no significant changes were observed between the two groups about pain and bleeding . Instead , we observed significant differences regarding tenesmus ( group A : 8.0±1.1 vs Group B : 5.4 ± 1.5 at 15 POD , p < 0.05 ; group A : 9.1±0.8 vs Group B : 5.7 ± 0.9 at 30 POD , p < 0.05 ) , pruritus ( group A : 7.1 ± 1.4 vs Group B : 4.8 ± 1 at 15 POD , p < 0.05 ; group A : 9.5 ± 0.5 vs Group B : 6.6 ± 0.8 at 30 POD , p < 0.05 ) and perianal weight ( group A : 7.2 ± 0.9 vs Group B : 6.2 ± 0.8 at 15 POD , p < 0.05 ; group A : 9.75 ± 0.4 vs Group B : 7.3 ± 0.9 at 30 POD , p < 0.05 ) . CONCLUSIONS Our results confirm the usefulness of this drug to reduce the prevalence and the importance of post-hemorrhoidectomy symptoms and make more comfortable the postoperative period Background In the past decade , several new surgical tools have revived the hope for an improved technique to treat radically hemorrhoids with less postoperative pain . Among these radiofrequency ( RF ) , excisional surgery seems to be safe , fast , and accompanied by less postoperative pain . The aim of this study was to evaluate and compare RF ( ligasure TM ) to conventional diathermy Milligan-Morgan hemorrhoidectomy ( MMH ) . Patients and methods Between January 2003 and July 2009 , 210 symptomatic patients were r and omized to undergo RF ( 118 patients ) or diathermy MMH ( 92 patients ) . Mean follow-up was 39 ± 16 months . Clinical outcome was assessed by vali date d question naire on postoperative symptoms and satisfaction . Primary endpoints were pain and wound healing . Secondary endpoints were operative time , early and late complications ( including recurrences ) , and patient satisfaction . Data was analyzed using chi-squared test and Fisher ’s exact test . Results Despite postoperative pain was less after RF , this difference was significant only for severe pain ( expressed as VAS score > 7 ) . Significant differences were observed in terms of wound healing . The two techniques were similar in terms of early and late complications . Conclusions RF hemorrhoidectomy is followed by reduced severe pain and better wound healing . However , in our experience , this is not followed by earlier return to daily activities Background Hemorrhoid is one of the most common surgical diseases occurring in the anorectal region . In this study , we evaluated the effect of ischiorectal fossa block on alleviating post hemorrhoidectomy pain . Methods In this study , 90 patients suffering from hemorrhoids were evaluated . They were r and omly divided into 3 groups . The first group had no block , the second group an ischiorectal block with placebo ( normal saline ) , and the third group a preemptive ischiorectal block with bupivacaine . Postoperative variables such as pain intensity , pethidine consumption , nausea , and vomiting were compared between the groups . Results The postoperative pain score in group 1 was 8.5 ± 1.3 and 8.1 ± 0.9 ( P = NS ) in group 2 . The post operative analgesic dem and was 3.1 ± 1.5 and 3.3 ± 1.8 hours in groups 1 and 2 , respectively ( P = NS ) . The post operative pain score and analgesic dem and were 4.2 ± 2.1 and 9.3 ± 2.7 hours , respectively , in group 3 ( P < 0.0001 ) . Conclusions Preemptive ischiorectal block reduces the posthemorrhoidectomy pain and opioid dem and INTRODUCTION Hemorrhoidal disease occurs in 50 % of people aged > 40 years and is the most common reason for anorectal surgery . Pain is the main complication . Multiple topical and systemic drugs have been investigated for pain control , but there is no ideal treatment . Metronidazole has been shown to decrease postoperative pain but is not used widely . OBJECTIVE To evaluate the effect of oral metronidazole versus placebo and to assess postoperative pain following hemorrhoidectomy . MATERIAL AND METHODS Controlled clinical trial in adult patients who underwent elective hemorrhoidectomy for grade III/IV hemorrhoids . Patients were assigned to receive metronidazole ( 500 mg q8 h orally ; study group , SG ) or placebo ( control group , CG ) for 7 days after surgery . Pain was assessed using a visual analog scale after surgery . Analgesic administration ( time and use of analgesics ) and resumption of daily life activities were also assessed . RESULTS Forty-four patients were included , 22 in each group . Postoperative pain differed significantly between the SG and CG at 6 h ( 3.86 ± 0.56 , 6.64 ± 1.49 ) , 12 h ( 5.59 ± 1.33 , 8.82 ± 0.79 ) , 24 h ( 6.86 ± 1.49 , 9.73 ± 0.45 ) , day 4 ( 5.32 ± 2.10 , 9.50 ± 0.59 ) , day 7 ( 3.14 Output:	Conclusion Pudendal nerve block , with or without general anaesthesia , is recommended for all patients undergoing haemorrhoidal surgery . Either closed haemorrhoidectomy , or open haemorrhoidectomy with electrocoagulation of the pedicle is recommended as the primary procedure .
MS2654	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : Hypothermia during and after major abdominal surgery decreases host defenses , increases the incidence of coagulopathy and may alter blood pressure , cardiac contractility and myocardial stability . Methods : We design ed a prospect i ve r and omized study to compare the benefits of a forced air warming system with warm blanket treatments in minimizing the effects of hypothermia on 64 morbidly obese patients undergoing Roux-en-Y gastric bypass . Results : Patients in the forced air warming group ( n = 32 ) had significantly higher perioperative body core temperature , lower central venous pressure and blood pressure readings , lower incidence of shivering , less blood loss intraoperatively and achieved a higher post anesthesia Aldrete Score than those patients in the warmed blanket group ( n = 32 ) . Conclusion : The forced air warming system is safe , cost effective and beneficial in minimizing the undesirable consequences of hypothermia in morbidly obese patients undergoing Roux-en-Y gastric bypass BACKGROUND Mild perioperative hypothermia , which is common during major surgery , may promote surgical-wound infection by triggering thermoregulatory vasoconstriction , which decreases subcutaneous oxygen tension . Reduced levels of oxygen in tissue impair oxidative killing by neutrophils and decrease the strength of the healing wound by reducing the deposition of collagen . Hypothermia also directly impairs immune function . We tested the hypothesis that hypothermia both increases susceptibility to surgical-wound infection and lengthens hospitalization . METHODS Two hundred patients undergoing colorectal surgery were r and omly assigned to routine intraoperative thermal care ( the hypothermia group ) or additional warming ( the normothermia group ) . The patient 's anesthetic care was st and ardized , and they were all given cefam and ole and metronidazole . In a double-blind protocol , their wounds were evaluated daily until discharge from the hospital and in the clinic after two weeks ; wounds containing culture-positive pus were considered infected . The patients ' surgeons remained unaware of the patients ' group assignments . RESULTS The mean ( + /- SD ) final intraoperative core temperature was 34.7 + /- 0.6 degrees C in the hypothermia group and 36.6 + /- 0.5 degrees C in the normothermia group ( P < 0.001 ) Surgical-wound infections were found in 18 of 96 patients assigned to hypothermia ( 19 percent ) but in only 6 of 104 patients assigned to normothermia ( 6 percent , P = 0.009 ) . The sutures were removed one day later in the patients assigned to hypothermia than in those assigned to normothermia ( P = 0.002 ) , and the duration of hospitalization was prolonged by 2.6 days ( approximately 20 percent ) in hypothermia group ( P = 0.01 ) . CONCLUSIONS Hypothermia itself may delay healing and predispose patients to wound infections . Maintaining normothermia intraoperatively is likely to decrease the incidence of infectious complications in patients undergoing colorectal resection and to shorten their hospitalizations BACKGROUND In-vitro studies indicate that platelet function and the coagulation cascade are impaired by hypothermia . However , the extent to which perioperative hypothermia influences bleeding during surgery remains unknown . Accordingly , we tested the hypothesis that mild hypothermia increases blood loss and allogeneic transfusion requirements during hip arthroplasty . METHODS Blood loss and transfusion requirements were evaluated in 60 patients undergoing primary , unilateral total hip arthroplasties who were r and omly assigned to normothermia ( final intraoperative core temperature 36.6 [ 0.4 ] degrees C ) or mild hypothermia ( 35.0 [ 0.5 ] degrees C ) . Crystalloid , colloid , scavenged red cells , and allogeneic blood were administered by strict protocol . FINDINGS Intra- and postoperative blood loss was significantly greater in the hypothermic patients : 2.2 ( 0.5 ) L vs 1.7 ( 0.3 ) L , p < 0.001 ) . Eight units of allogeneic packed red cells were required in seven of the 30 hypothermic patients , whereas only one normothermic patient required a unit of allogeneic blood ( p < 0.05 for administered volume ) . A typical decrease in core temperature in patients undergoing hip arthroplasty will thus augment blood loss by approximately 500 mL. INTERPRETATION The maintenance of intraoperative normothermia reduces blood loss and allogeneic blood requirements in patients undergoing total hip arthroplasty Background Shivering is rare during general anesthesia . This observation suggests that anesthetics profoundly impair shivering . However , the effects of surgical doses of volatile anesthetics on control of shivering have yet to be evaluated . Furthermore , the effects of desflurane on sweating and thermoregulatory vasoconstriction remain unknown . Accordingly , the authors determined the concentration‐dependent effects of desflurane on sweating , vasoconstriction , and shivering We have investigated patients undergoing cardiac surgery with hypothermic bypass to see if the addition of skin surface warming during systemic rewarming on bypass ( heated group , n = 43 ) would improve perioperative thermal balance compared with conventional management without skin warming ( control group , n = 43 ) in an open , r and omized , controlled study . Intraoperative skin warming with a water mattress and forced warm air over the face , neck and shoulders attenuated the afterdrop in nasopharyngeal temperature after weaning from bypass ( 2.3 ( 1.2 ) degrees C and 1.3 ( 0.5 ) degrees C in the control and heated groups , respectively ) ( P < 0.05 ) and result ed in higher rectal temperature 4 h after surgery . Despite similar st and ard coagulation tests , heated patients had lower blood loss via the chest tubes ( 600 ( 264 ) ml vs 956 ( 448 ) ml in control patients ) ( P < 0.05 ) and less requirements for i.v . colloid infusion ( 1662 ( 404 ) ml vs 1994 ( 389 ) ml ) ( P < 0.05 ) . There was a significant inverse correlation between rectal temperature on arrival in the ICU and postoperative blood loss ( r = 0.57 , P < 0.001 ) . These data suggest that additional skin surface warming with a water mattress and forced warm air helped to preserve perioperative thermal balance and may contribute to reduced bleeding after cardiac surgery OBJECTIVE We evaluated the performance of a new temperature management system ( A rct ic Sun , Medivance , Inc. ) in maintaining normothermia during off-pump coronary artery bypass ( OPCAB ) . PATIENTS AND METHODS Ninety-eight unselected patients were prospect ively r and omized to either a conventional temperature management method ( consisting of a sterile forced-air warming blanket , warm intravenous fluids , and maintenance of a warm OR ) or the new A rct ic Sun system ( two pads , A rct ic Sun Energy Transfer Pads placed on the patient 's back with temperature-controlled water flowing through the pads ) . RESULTS The mean age , body surface area , and total operating time were similar in both groups . Despite significantly lower room temperatures ( p<0.001 ) in the A rct ic Sun group , the system maintained higher bladder and nasopharyngeal temperatures ( p<0.001 and p<0.001 , respectively ) . A core temperature of at least 36 degrees C was achieved in 97 % of the A rct ic Sun patients compared with 42 % in the conventional group . Additionally , intra-operative blood loss for the A rct ic Sun patients was significantly less ( p=0.01 ) . CONCLUSIONS The A rct ic Sun system significantly outperformed conventional techniques in achieving and maintaining normothermia during off-pump coronary artery bypass OBJECTIVE Perioperative hypothermia might be detrimental to the patient undergoing off-pump coronary artery bypass surgery . We assessed the efficacy of the Allon thermoregulation system ( MTRE Advanced Technologies Ltd , Or-Akiva , Israel ) compared with that of routine thermal care in maintaining normothermia during and after off-pump coronary artery bypass surgery . METHODS Patients undergoing off-pump coronary artery bypass surgery were perioperatively and r and omly warmed with the 2 techniques ( n = 45 per group ) . Core temperature , hemodynamics , and troponin I , interleukin 6 , interleukin 8 , and interleukin 10 blood levels were assessed . RESULTS The mean temperature of the patients in the Allon thermoregulation system group ( AT group ) was significantly ( P < .005 ) higher than that of the patients receiving routine thermal care ( the RTC group ) ; less than 40 % of the latter reached 36 degrees C compared with 100 % of the former . The cardiac index was higher and the systemic vascular resistance was lower ( P < .05 ) by 16 % and 25 % , respectively , in the individuals in the AT group compared with in the individuals in the RTC group during the 4 postoperative hours . End-of-surgery interleukin 6 levels and 24-hour postoperative troponin I levels were significantly ( P < .01 ) lower in the patients in the AT group than in the RTC group . The RTC group 's troponin levels closely correlated with their interleukin 6 levels at the end of the operation ( R = 0.51 , P = .002 ) . CONCLUSIONS Unlike routine thermal care , the Allon thermoregulation system maintains core normothermia in more than 80 % of patients undergoing off-pump coronary artery bypass surgery . Normothermia is associated with better cardiac and vascular conditions , a lower cardiac injury rate , and a lower inflammatory response . The close correlation between the increased interleukin 6 and troponin I levels in the routine thermal care group indicates a potential deleterious effect of lowered temperature on the patient 's outcome STUDY OBJECTIVE To evaluate the postoperative hemodynamic and thermoregulatory consequences of intraoperative core hypothermia . DESIGN Prospect i ve , r and omized clinical trial . SETTING Operating room and postanesthesia care unit of a university hospital . PATIENTS 74 healthy , ASA status I , II , and III patients ( average age 58 yrs ) undergoing elective colon surgery . INTERVENTIONS Patients were r and omly assigned to be kept normothermic or approximately 2.5 degrees C hypothermic during surgery . Anesthesia was maintained with isoflurane , nitrous oxide , and fentanyl . Postoperatively , surgical pain was treated with patient-controlled analgesia ( PCA ) opioid . MEASUREMENTS AND MAIN RESULTS An observer blinded to group assignment and core temperatures evaluated shivering , thermal comfort , surgical pain , heart rates ( HRs ) , and blood pressures ( BPs ) during the first six postoperative hours . Morphometric characteristics , oxygen saturation , fluid balance , PCA-administered opioid , and visual analog pain scores were comparable in the two groups . Hypothermic patients felt uncomfortably cold during recovery , and their postoperative core temperatures remained significantly less than in the normothermic patients for more than four hours . Peripheral vasoconstriction and shivering were common in the hypothermic patients but rare in those kept normothermic . HRs and BPs were comparable in the two groups . CONCLUSIONS These data confirm that the effects of intraoperative hypothermia on postoperative HR and BP are modest in relatively young , generally healthy patients . In contrast , intraoperative hypothermia caused substantial postoperative thermal discomfort , and full recovery from hypothermia required many hours . Delayed return to care normothermia apparently result ed largely from postoperative thermoregulatory impairment An attempt was made to reduce heat loss in elderly patients undergoing major abdominal surgery . Two groups were studied . In one group , efforts were made to minimize heat loss by using a hot-water humidifier in the anaesthetic circuit , a hot-water circulating mattress under the patient and warming all i.v . fluids . Otherwise , the surgical and anaesthetic techniques were comparable . The same anaesthetic technique of nitrous oxide , oxygen , pancuronium and fentanyl with intermittent positive pressure ventilation was used in all cases . Nitrogen loss was measured in urine collected over 48 h from an indwelling urinary catheter inserted soon after induction of anaesthesia . Prevention of heat loss during anaesthesia and postoperative recovery caused a significant reduction in nitrogen loss OBJECTIVE To assess the relationship between body temperature and cardiac morbidity during the perioperative period . DESIGN R and omized controlled trial comparing routine thermal care ( hypothermic group ) to additional supplemental warming care ( normothermic group ) . SETTING Operating rooms and surgical intensive care unit at an academic medical center . SUBJECTS Three hundred patients undergoing abdominal , thoracic , or vascular surgical procedures who either had documented coronary artery disease or were at high risk for coronary disease . OUTCOME MEASURE The relative risk of a morbid cardiac event ( unstable angina/ischemia , cardiac arrest , or myocardial infa rct ion ) according to thermal treatment . Cardiac outcomes were assessed in a double-blind fashion . RESULTS Mean core temperature after surgery was lower in the hypothermic group ( 35.4+/-0.1 degrees C ) than in the normothermic group ( 36.7+/-0.1 degrees C ) ( P<.001 ) and remained lower Output:	Maintaining perioperative normothermia reduces blood loss and transfusion requirement by clinical ly important amounts
MS2655	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background / Objectives . Vagal block therapy ( vBloc ) is effective for moderate to severe obesity at one year . Subjects/ Methods . The ReCharge trial is a double-blind , r and omized controlled clinical trial of 239 participants with body mass index ( BMI ) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions . Interventions were implantation of either vBloc or Sham devices and weight management counseling . Mixed models assessed percent excess weight loss ( % EWL ) and total weight loss ( % TWL ) in intent-to-treat analyses . At 18 months , 142 ( 88 % ) vBloc and 64 ( 83 % ) Sham patients remained enrolled in the study . Results . 18-month weight loss was 23 % EWL ( 8.8 % TWL ) for vBloc and 10 % EWL ( 3.8 % TWL ) for Sham ( P < 0.0001 ) . vBloc patients largely maintained 12-month weight loss of 26 % EWL ( 9.7 % TWL ) . Sham regained over 40 % of the 17 % EWL ( 6.4 % TWL ) by 18 months . Most weight regain preceded unblinding . Common adverse events of vBloc through 18 months were heartburn/dyspepsia and abdominal pain ; 98 % of events were reported as mild or moderate and 79 % had resolved . Conclusions . Weight loss with vBloc was sustained through 18 months , while Sham regained weight between 12 and 18 months . vBloc is effective with a low rate of serious complications BACKGROUND A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss ( EWL ) in an initial clinical trial in obese patients . The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia , Norway , and Switzerl and . METHODS Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms . In the second trial , vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device . The patients were followed up for 6 months to assess the EWL and safety , including adverse events . RESULTS In the initial clinical trial , vagal blocking algorithm duration s of 90 - 150 s were associated with greater EWL compared with either shorter or longer algorithm duration s ( P<.01 ) . The second trial enrolled 27 patients ( mean body mass index 39.3+/-.8 kg/m2 ) to evaluate a 120-s blocking algorithm . At 6 months , greater EWL was achieved ( 22.7%+/-3.1 % , n=24 ) compared with the initial study and first-generation device ( 14.2%+/-2.2 % , n=29 , P=.03 ) . In both trials , an association was found between the number of 90 - 150-s algorithms delivered daily and greater EWL ( P=.03 ) . No deaths , unanticipated device-related adverse events , or medically serious adverse events were associated with the device . CONCLUSION This second-generation vagal blocking device , using a therapy algorithm of 120-s duration , result ed in a clinical ly acceptable safety profile and significantly greater EWL compared with the first-generation device delivering a wider range of therapy algorithm duration BACKGROUND A new medical device uses high-frequency electrical algorithms to create intermittent vagal blocking ( VBLOC therapy ) . The aim is to assess the effects of vagal blocking on excess weight loss ( EWL ) , safety , dietary intake , and vagal function . METHODS An open-label , 3-center study was conducted in obese subjects ( body mass index [ BMI ] 35 - 50 kg/m(2 ) ) . Electrodes were implanted laparoscopically on both vagi near the esophagogastric junction to provide electrical block . Patients were followed for 6 months for body weight , safety , electrocardiogram , dietary intake , satiation , satiety , and plasma pancreatic polypeptide ( PP ) response to sham feeding . To specifically assess device effects alone , no diet or exercise programs were instituted . RESULTS Thirty-one patients ( mean BMI , 41.2 + /- 1.4 kg/m(2 ) ) received the device . Mean EWL at 4 and 12 weeks and 6 months after implant was 7.5 % , 11.6 % , and 14.2 % , respectively ( all P < .001 ) ; 25 % of patients lost > 25 % EWL at 6 months ( maximum , 36.8 % ) . There were no deaths or device-related serious adverse events ( AEs ) . Calorie intake decreased by > 30 % at 4 and 12 weeks and 6 months ( all P < or= .01 ) , with earlier satiation ( P < .001 ) and reduced hunger ( P = .005 ) . After 12 weeks , plasma PP responses were suppressed ( 20 + /- 7 vs 42 + /- 19 pg/mL ) . Average percent EWL in patients with PP response < 25 pg/mL was double that with PP response > 25 pg/mL ( P = .02 ) . Three patients had serious AEs that required brief hospitalization , 1 each for lower respiratory tract , subcutaneous implant site seroma , and Clostridium difficile diarrhea . CONCLUSIONS Intermittent , intra-abdominal vagal blocking is associated with significant EWL and a desirable safety profile AIMS Uncoordinated contraction of the external urethral sphincter is prevalent in individuals with spinal cord injury and can prevent bladder voiding . The aim of this study was to demonstrate that complete and reversible sinusoidal high frequency alternating current ( HFAC ) conduction block of the pudendal nerves ( PN ) can eliminate external urethral sphincter activation and produce low residual bladder voiding . METHODS In four cats , tripolar nerve cuff electrodes were implanted bilaterally on both pudendal nerves and on both extradural S2 roots . Bladder and urethral pressures , bladder volumes and flow were recorded . Bilateral HFAC was applied to determine voltage and frequency parameters result ing in bilateral PN conduction block . Sacral root stimulation provided bladder activation . R and omized sets of voiding trials were conducted with and without HFAC PN block . Additional voiding trials were conducted following bilateral PN neurotomy to eliminate somatic sphincter resistance and provide an estimate of voiding with complete block . RESULTS Effective bilateral PN block and voiding was obtained in three of four animals . Application of bilateral PN HFAC stimulation improved voiding from 2 + /- 4 % to 77 + /- 18 % of the initial bladder volume and significantly ( P < 0.001 ) reduced maximum bladder pressure during voiding . Voiding in trials with PN block was not significantly different from voiding following PN neurotomy ( 82 + /- 19 % , P = 0.51 ) . CONCLUSIONS These results demonstrate that bilateral HFAC block of the PN can produce effective voiding . Neural prostheses using this approach may provide an alternative method for producing micturition for people with spinal cord injury OBJECTIVE To investigate the effect of unmodulated 5-kHz alternating current on mechanical pain threshold ( MPT ) , heat pain threshold ( HPT ) , tactile threshold ( TT ) , and peripheral nerve conduction ( PNC ) compared with transcutaneous electrical nerve stimulation ( TENS ) and sham stimulation . SETTING National referral center . DESIGN R and omized , double-blind , placebo-controlled crossover trial . PARTICIPANTS Healthy volunteers ( N=38 ) . No dropouts or adverse events were reported . INTERVENTION TENS , unmodulated 5-kHz currents , and sham stimulation were applied on the radial nerve for 20 minutes with a 24-hour washout period between them and concealed intervention allocation . MAIN OUTCOME MEASURES Four measures were taken : before , during , and 2 after the interventions . Algometry was used to assess MPT , a Peltier thermode for HPT using the method of limits , Von Frey filaments for TT , and radial nerve compound action potential . RESULTS No differences were observed on MPT , HPT , and PNC when 5-kHz current and TENS were compared . However , TT increased 56.2mN ( 95 % confidence interval [ CI ] , 28.8 - 83.6 ) in the TENS group compared with the 5-kHz current group during intervention . Compared with sham stimulation during intervention , MPT increased 4.7N ( 95 % CI , 0.3 - 9.2 ) using 5-kHz current and 10.4N ( 95 % CI , 3.5 - 17.3 ) with TENS . TT increased 17.2mN ( 95 % CI , 4.7 - 29.7 ) with 5-kHz current and 73.4mN ( 95 % CI , 47.5 - 99.2 ) with TENS . However , HPT increased 1.0 ° C ( 95 % CI , 0.2 - 2.0 ) only with TENS . For the PNC , no differences were found among the 3 groups . CONCLUSIONS Unmodulated 5-kHz current produced an increase in somatosensory thresholds that was greater than placebo but not when compared with TENS ; however , participants perceived 5-kHz currents to be more comfortable and showed more habituation to them Background Intermittent , reversible intraabdominal vagal blockade ( VBLOC ® Therapy ) demonstrated clinical ly important weight loss in feasibility trials . EMPOWER , a r and omized , double-blind , prospect i ve , controlled trial was conducted in USA and Australia . Methods Five hundred three subjects were enrolled at 15 centers . After informed consent , 294 subjects were implanted with the vagal blocking system and r and omized to the treated ( n = 192 ) or control ( n = 102 ) group . Main outcome measures were percent excess weight loss ( percent EWL ) at 12 months and serious adverse events . Subjects controlled duration of therapy using an external power source ; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission . Devices in both groups performed regular , low-energy safety checks . Data are mean ± SEM . Results Study subjects consisted of 90 % females , body mass index of 41 ± 1 kg/m2 , and age of 46 ± 1 years . Device-related complications occurred in 3 % of subjects . There was no mortality . 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group . Weight loss was related linearly to hours of device use ; treated and controls with ≥12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL , respectively . Conclusions VBLOC ® therapy to treat morbid obesity was safe , but weight loss was not greater in treated compared to controls ; clinical ly important weight loss , however , was related to hours of device use . Post- study analysis suggested that the system electrical safety checks ( low charge delivered via the system for electrical impedance , safety , and diagnostic checks ) may have contributed to weight loss in the control group Output:	High-frequency alternating currents using frequencies of > 4–5 kHz effectively block nerve conduction . There is no consensus about the block mechanism , although it has been showed that the frequency is a key factor to produce K+ channels activation or Na+ channels inactivation . The nerve block produced by currents quickly reverts without causing further damage to the nerve .
MS2656	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : In addition to lipid lowering , further pleotropic effects of statins have been postulated . We aim ed to study if the various pleotropic effects are due indirectly to the modulation of adipocytokines . Material s and methods : We studied the effect of atorvastatin on insulin sensitivity and the plasma adiponectin and leptin concentrations . Our r and omized open labeled study had 29 hyperlipidemic Type 2 diabetic patients ( 14 females , 15 males , mean age 60.0±2.2 yr ) . They were r and omized into three 12-week atorvastatin intervention types . Each day patients were given either 10 mg ( no.=10 ) , 20 mg ( no.=10 ) or 40 mg ( no.=9 ) . Evaluations were performed before and after intervention . Results : All baseline characteristics were statistically identical in the 3 groups . Drop in total cholesterol , LDL-cholesterol , and triglyceride levels were measured at the end . With 10 mg the drop was 30 % , 37 % , and 30 % . The 20 mg group was 43 % , 54 % , and 34 % . The 40 mg group was 42 % , 51 % , and 27 % . Groups had no significant change of body mass index , HDL-cholesterol , and glycated hemoglobin levels . Also , levels of insulin , adiponectin , leptin , homeostasis model assessment index ( HOMA ) and Quantitative Insulin Sensitivity Check Index ( QUICKI ) stayed the same . Pooled parameters of all 29 patients showed no difference in levels of insulin , adiponectin , leptin , HOMA , and QUICKI before and after treatment . Conclusions : Atorvstatin does not affect insulin sensitivity and the adiponectin or leptin levels in hyperlipidemic Type 2 diabetes INTRODUCTION Diabetes is a prothrombotic state involving a more thrombogenic fibrin network . In the present study we investigated the effects of lipid-lowering therapy with atorvastatin on fibrin network structure and platelet-derived microparticles in patients with type 1 diabetes and dyslipidemia . MATERIAL S AND METHODS Twenty patients were treated with atorvastatin ( 80 mg daily ) or placebo during 2 months in a r and omized , double-blind , cross-over study . Fibrin network permeability , expression of glycoprotein IIIa , P-selectin and tissue factor on platelet-derived microparticles , plasma endogenous thrombin potential , plasminogen activator inhibitor-1 and tissue plasminogen activator antigen levels were assessed . Additionally , levels of plasma fibrinogen , high-sensitivity C-reactive protein and glycated haemoglobin were measured . RESULTS During treatment with atorvastatin , fibrin network permeability increased ( p=0.01 ) , while endogenous thrombin potential and expression of glycoprotein IIIa , P-selectin and tissue factor decreased ( p<0.01 ) . In vitro experiments indicated that platelet-derived microparticles influence the fibrin network formation as fibrin network permeability decreased significantly when platelet-derived microparticles were added to normal plasma . Baseline levels of plasminogen activator inhibitor-1 and tissue plasminogen activator antigen as well as plasma fibrinogen and high-sensitivity C-reactive protein were within reference values and not significantly changed during atorvastatin treatment , while glycated haemoglobin increased 0.3 % ( p<0.001 ) . CONCLUSIONS Novel treatment effects were found in patients with type 1 diabetes and dyslipidemia during atorvastatin therapy , i.e. a more porous fibrin network , to which reduced expression of glycoprotein IIIa , P-selectin and tissue factor on platelet-derived microparticles may contribute . The observed impairment of glycemic control during long-term statin treatment deserves attention Summary Background The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome . No study , however , has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease ( CHD ) in hypertensive patients who are not conventionally deemed dyslipidaemic . Methods Of 19 342 hypertensive patients ( aged 40–79 years with at least three other cardiovascular risk factors ) r and omised to one of two antihypertensive regimens in the Anglo-Sc and inavian Cardiac Outcomes Trial , 10 305 with nonfasting total cholesterol concentrations 6.5 mmol/L or less were r and omly assigned additional atorvastatin 10 mg or placebo . These patients formed the lipid-lowering arm of the study . We planned follow-up for an average of 5 years , the primary endpoint being non-fatal myocardial infa rct ion and fatal CHD . Data were analysed by intention to treat . Findings Treatment was stopped after a median follow-up of 3.3 years . By that time , 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group ( hazard ratio 0.64 [ 95 % CI 0.50–0.83 ] , p = 0.0005 ) . This benefit emerged in the first year of follow-up . There was no significant heterogeneity among prespecified subgroups . Fatal and non-fatal stroke ( 89 atorvastatin vs 121 placebo , 0.73 [ 0.56–0.96 ] , p = 0.024 ) , total cardiovascular events ( 389 vs 486 , 0.79 [ 0.69–0.90 ] , p = 0.0005 ) , and total coronary events ( 178 vs 247 , 0.71 [ 0.59–0.86 ] , p = 0.0005 ) were also significantly lowered . There were 185 deaths in the atorvastatin group and 212 in the placebo group ( 0.87 [ 0.71–1.06 ] , p = 0.16 ) . Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months , and by 1.1 mmol/L after 3 years of follow-up . Interpretation The reductions in major cardiovascular events with atorvastatin are large , given the short follow-up time . These findings may have implication s for future lipid-lowering guidelines OBJECTIVES We investigated whether atorvastatin might decrease insulin sensitivity and increase ambient glycemia in hypercholesterolemic patients . BACKGROUND Clinical trials suggest that some statin treatments might increase the incidence of diabetes despite reductions in low-density lipoprotein ( LDL ) cholesterol and improvement in endothelial dysfunction . METHODS A r and omized , single-blind , placebo-controlled parallel study was conducted in 44 patients taking placebo and in 42 , 44 , 43 , and 40 patients given daily atorvastatin 10 , 20 , 40 , and 80 mg , respectively , during a 2-month treatment period . RESULTS Atorvastatin 10 , 20 , 40 , and 80 mg significantly reduced LDL cholesterol ( 39 % , 47 % , 52 % , and 56 % , respectively ) and apolipoprotein B levels ( 33 % , 37 % , 42 % , and 46 % , respectively ) after 2 months of therapy when compared with either baseline ( all p < 0.001 by paired t test ) or placebo ( p < 0.001 by analysis of variance [ ANOVA ] ) . Atorvastatin 10 , 20 , 40 , and 80 mg significantly increased fasting plasma insulin ( mean changes : 25 % , 42 % , 31 % , and 45 % , respectively ) and glycated hemoglobin levels ( 2 % , 5 % , 5 % , and 5 % , respectively ) when compared with either baseline ( all p < 0.05 by paired t test ) or placebo ( p = 0.009 for insulin and p = 0.008 for glycated hemoglobin by ANOVA ) . Atorvastatin 10 , 20 , 40 , and 80 mg decreased insulin sensitivity ( 1 % , 3 % , 3 % , and 4 % , respectively ) when compared with either baseline ( p = 0.312 , p = 0.008 , p < 0.001 , and p = 0.008 , respectively , by paired t test ) or placebo ( p = 0.033 by ANOVA ) . CONCLUSIONS Despite beneficial reductions in LDL cholesterol and apolipoprotein B , atorvastatin treatment result ed in significant increases in fasting insulin and glycated hemoglobin levels consistent with insulin resistance and increased ambient glycemia in hypercholesterolemic patients . ( Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients ; NCT00745836 ) BACKGROUND Despite established effects of atorvastatin on level of serum lipid profile in patients with different underlying clinical conditions , the effects of this drug on other serum biomarkers remain uncertain . We examined the effects of atorvastatin therapy on lipid profile , glycemic control , and liver enzymes in patients with ischemic cerebrovascular accident without any history or clinical evidence s of diabetes , heart failure , renal failure , or hepatic disease . METHODS In a r and omized double-blinded controlled trial , 140 hospitalized patients with an ischemic cerebrovascular accident were included and r and omly assigned to receive either atorvastatin 40 mg ( n = 70 ) or atorvastatin 20 mg daily ( n = 70 ) for 3 months . The levels of biomarkers were measured at the time of administrating drugs as well as at the time of completing the treatment . RESULTS A significant reduction was revealed in serum triglyceride , total cholesterol , low-density lipoprotein , non-high-density lipoprotein ( HDL ) cholesterol , and also aspartate aminotransferase levels as well as a significant increase in serum HDL level following administration of atorvastatin in both case and control groups who received the atorvastatin 40 mg/day and 20 mg/day , respectively ( all P < 0.050 ) . Although a significant increase in fasting blood sugar and hemoglobin A1c was observed in the case group received atorvastatin 40 mg/day ( both P < 0.001 ) , but this elevation was not occurred in another group treated with lower dose of the drug ( both P > 0.050 ) . CONCLUSION Daily administration of 20 mg and 40 mg doses of atorvastatin for 3 months provides improvement in serum lipid profiles ; however , because of interfering effect of high-dose atorvastatin on glycemic control status , the use of the former dose may be preferred . This is very important in these patients because the positive effects of high-dose atorvastatin in stroke patients are not confirmed In this prospect i ve study , we examined the effect of atorvastatin treatment on baroreflex sensitivity ( BRS ) in subjects with type 2 diabetes . A total of 79 patients with type 2 diabetes with dyslipidaemia were recruited . A total of 46 subjects were enrolled to atorvastatin 10 mg daily and low-fat diet and 33 patients to low-fat diet only . BRS was assessed non-invasively using the sequence method at baseline , 3 , 6 and 12 months . Treatment with atorvastatin increased BRS after 12 months ( from 6.46 ± 2.79 ms/mmHg to 8.05 ± 4.28 ms/mmHg , p = 0.03 ) , while no effect was seen with low-fat diet . Further sub- analysis according to obesity status showed that BRS increased significantly only in the non-obese group ( p = 0.036 ) . A low dose of atorvastatin increased BRS in non-obese subjects with type 2 diabetes and dyslipidaemia after 1-year treatment . This finding emphasizes the beneficial effect of atorvastatin on cardiovascular system , beyond the lipid-lowering effects CONTEXT Statins have been shown to improve hyper and rogenism in women with polycystic ovary syndrome ( PCOS ) . However , their use has also been associated with impairment of glucose metabolism and an increased risk of type 2 diabetes mellitus . Because women with PCOS are prone to disturbances in glucose metabolism , statin therapy could also have negative effects . OBJECTIVE Our objective was to explore the effects of atorvastatin therapy on hormonal and metabolic parameters in women with PCOS . DESIGN AND SETTING We conducted a r and omized , double-blind , placebo-controlled 6-month follow-up study conducted at Oulu University Hospital , Finl and . PATIENTS Women with PCOS ( Rotterdam criteria ) were treated with atorvastatin ( 20 m Output:	Other studies showed that fasting plasma glucose and HbA1c levels were increased by atorvastatin . The majority of these articles showed that patients who used atorvastatin had a higher dose-dependent risk of developing NOD . Conclusion This systematic review suggests that there is an association between atorvastatin treatment and NOD . Moreover , it showed that atorvastatin in high dose causes worsening of the glycemic control in patients with DM
MS2657	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: STUDY DESIGN Prospect i ve cohort study . OBJECTIVE To assess the effect of 6 weeks of balance training on sensorimotor measures previously found to be deficient in participants with chronic ankle instability ( CAI ) . BACKGROUND CAI is the tendency toward repeated ankle sprains and recurring symptoms , occurring in 40 % to 70 % of individuals who have previously sustained a lateral ankle sprain . Recent studies have found deficits in sensorimotor measures in individuals with CAI . As balance training is a common component of ankle rehabilitation , underst and ing its effect on the sensorimotorsystem in individuals with CAI may enable us to optimize protocol s to better utilize this rehabilitation method . METHODS Twelve participants with CAI and 9 healthy volunteers participated . Independent variables were group ( CAI , control ) and time ( pretraining , posttraining ) . Participants with CAI who completed a 6-week balance training program and healthy controls who did not get any training were pretested and posttested at the beginning and at the end of 6 weeks . RESULTS The individuals in the CAI group who performed balance training demonstrated better performance than control participants on baseline adjusted posttraining measures of dynamic balance in the anterior medial ( P = .021 ) , medial ( P = .048 ) , and posterior medial directions ( P = .030 ) ; motoneuron pool excitability Hmax/Mmax ratio ( P = .044 ) and single-limb presynaptic inhibition ( P = .012 ) ; and joint position sense inversion variable error ( P = .017 ) . It may be of note that no systematic differences were detected for static balance or plantar flexion joint position sense tasks . CONCLUSIONS After 6 weeks of balance training , individuals with CAI demonstrated enhanced dynamic balance , inversion joint position sense , and changes in motoneuron pool excitability compared to healthy controls who did not train . LEVEL OF EVIDENCE Therapy , level 2b Objectives The purpose of the international multicenter prospect i ve single arm clinical trial was to evaluate restorative neurostimulation eliciting episodic contraction of the lumbar multifidus for treatment of chronic mechanical low back pain ( CMLBP ) in patients who have failed conventional therapy and are not c and i date s for surgery or spinal cord stimulation ( SCS ) . Material s and Methods Fifty‐three subjects were implanted with a neurostimulator ( ReActiv8 , Mainstay Medical Limited , Dublin , Irel and ) . Leads were positioned bilaterally with electrodes close to the medial branch of the L2 dorsal ramus nerve . The primary outcome measure was low back pain evaluated on a 10‐Point Numerical Rating Scale ( NRS ) . Responders were defined as subjects with an improvement of at least the Minimal Clinical ly Important Difference ( MCID ) of ≥2‐point in low back pain NRS without a clinical ly meaningful increase in LBP medications at 90 days . Secondary outcome measures included Oswestry Disability Index ( ODI ) and Quality of Life ( QoL ; EQ‐5D ) . Results For 53 subjects with an average duration of CLBP of 14 years and average NRS of 7 and for whom no other therapies had provided satisfactory pain relief , the responder rate was 58 % . The percentage of subjects at 90 days , six months , and one year with ≥MCID improvement in single day NRS was 63 % , 61 % , and 57 % , respectively . Percentage of subjects with ≥MCID improvement in ODI was 52 % , 57 % , and 60 % while those with ≥MCID improvement in EQ‐5D was 88 % , 82 % , and 81 % . There were no unanticipated adverse events ( AEs ) or serious AEs related to the device , procedure , or therapy . The initial surgical approach led to a risk of lead fracture , which was mitigated by a modification to the surgical approach . Conclusions Electrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for CMLBP . Results demonstrate clinical ly important , statistically significant , and lasting improvement in pain , disability , and Abstract The purpose of this investigation was to examine the effects of the combination of chronic ankle instability ( CAI ) and altered visual focus on strategies for dynamic stability during a drop-jump task . Nineteen participants with self-reported CAI and 19 healthy participants performed a drop-jump task in looking-up and looking-down conditions . For the looking-up condition , participants looked up and read a r and om number that flashed on a computer monitor . For the looking-down condition , participants focused their vision on the force plate . Sagittal- and frontal-plane kinematics in the hip , knee and ankle were calculated at the time points of 100 ms pre-initial foot contact to ground and at IC . The result ant vector time to stabilisation was calculated with ground reaction force data . The CAI group demonstrated less hip flexion at the point of 100 ms pre-initial contact ( P < 0.01 ) , and less hip flexion ( P = 0.03 ) and knee flexion at initial contact ( P = 0.047 ) compared to controls . No differences in kinematics or dynamic stability were observed in either looking-up or looking-down conditions ( P > 0.05 ) . Altered visual focus did not influence movement patterns during the drop-jump task , but the presence of CAI did . The current data suggests that central ly mediated changes associated with CAI may lead to global alterations in the sensorimotor control CONTEXT Focal ankle-joint cooling ( FAJC ) has been shown to increase Hoffmann ( H ) reflex amplitudes of select leg muscles while subjects lie prone , but it is unknown whether the neurophysiological cooling effects persist in st and ing . OBJECTIVE To assess the effects of FAJC on H-reflexes of the soleus and fibularis longus during 3 body positions ( prone , bipedal , and unipedal stances ) in individuals with and without chronic ankle instability ( CAI ) . DESIGN Crossover . SETTING Laboratory . PARTICIPANTS 15 young adults with CAI ( 9 male , 6 female ) and 15 healthy controls . INTERVENTION All subjects received both FAJC and sham treatments on separate days in a r and omized order . FAJC was accomplished by applying a 1.5-L plastic bag filled with crushed ice to the ankle for 20 min . Sham treatment involved room-temperature c and y corn . MAIN OUTCOME MEASURES Maximum amplitudes of H-reflexes and motor ( M ) waves were recorded while subjects lay prone and then stood in quiet bipedal and unipedal stances before and immediately after each treatment . Primary outcome measures were H(max):M(max ) ratios for the soleus and fibularis longus . Three-factor ( group × treatment condition × time ) repeated- measures ANOVAs and Fisher LSD tests were performed for statistical analyses . RESULTS Significant interactions of treatment condition by time for prone H(max):M(max ) ratios were found in the soleus ( P = .001 ) and fibularis longus ( P = .003 ) . In both muscles , prone H(max):M(max ) ratios moderately increased after FAJC but not after sham treatment . The CAI and healthy groups responded similarly to FAJC . In contrast , there were no significant interactions or main effects in the bipedal and unipedal stances in either muscle ( P > .05 ) . CONCLUSIONS FAJC moderately increased H-reflex amplitudes of the soleus and fibularis longus while subjects were prone but not during bipedal or unipedal st and ing . These results were not different between groups with and without CAI OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity We do not know the impact an ankle sprain has on physical activity levels across the lifespan . With the negative consequences of physical inactivity well established , underst and ing the effect of an ankle sprain on this outcome is critical . The objective of this study was to measure physical activity across the lifespan after a single ankle sprain in an animal model . Thirty male mice ( CBA/J ) were r and omly placed into one of three groups : the transected calcaneofibular ligament ( CFL ) group , the transected anterior talofibular ligament (ATFL)/CFL group , and a SHAM group . Three days after surgery , all of the mice were individually housed in a cage containing a solid surface running wheel . Physical activity levels were recorded and averaged every week across the mouse 's lifespan . The SHAM mice ran significantly more distance each day compared to the remaining two running groups ( post hoc p = 0.011 ) . Daily duration was different between the three running groups ( p = 0.048 ) . The SHAM mice ran significantly more minutes each day compared to the remaining two running groups ( post hoc p=0.046 ) while the ATFL/CFL mice ran significantly less minutes each day ( post hoc p = 0.028 ) compared to both the SHAM and CFL only group . The SHAM mice ran at a faster daily speed versus the remaining two groups of mice ( post hoc p = 0.019 ) and the ATFL/CFL mice ran significantly slower each day compared to the SHAM and CFL group ( post hoc p = 0.005 ) . The results of this study indicate that a single ankle sprain significantly decreases physical activity across the lifespan in mice . This decrease in physical activity can potentially lead to the development of numerous chronic diseases . An ankle sprain thus has the potential to lead to significant long term health risks if not treated appropriately . Key pointsA single ankle significantly decreased physical activity levels in mice across the lifespan . Decreased physical activity could significantly negatively impact overall health if not modified . Initial treatment and rehabilitation of ankle sprains needs to be studied to determine ways to keep physical activity levels up after injury While GABA(B ) receptors are thought to have an important role in mediating long interval intracortical inhibition ( LICI ) in the human motor cortex , the effect of a selective GABA(B ) receptor agonist on this measure has not been directly tested . Nine healthy volunteers ingested either 50 mg baclofen ( BAC ) or placebo ( PBO ) in a r and omized , double blind crossover design , with the second session one week later . We used transcranial magnetic stimulation to assess motor threshold , motor evoked potential ( MEP ) amplitude , cortical silent period ( CSP ) duration , short interval intracortical inhibition ( SICI ) and LICI before and 90 min following drug intake . There was no specific effect of drug on motor threshold , MEP amplitude or CSP duration . BAC result ed in a significant increase in LICI ( P=0.002 ) and a significant decrease in SICI ( P=0.046 ) while PBO had no effect . Our findings demonstrate that the enhanced GABA(B ) receptor activation results in differential effects on these two measures of intracortical inhibition in the human motor cortex . The increase in LICI is likely to be a result of increased GABA(B ) receptor mediated inhibitory post-synaptic potentials , while the reduction in SICI may relate to the activation of pre-synaptic GABA(B ) receptors reducing GABA release OBJECTIVES We aim ed to present a unique prospect i ve neurological data set for participants who experienced an ACL injury . DESIGN Prospect i ve longitudinal case-control . METHODS High school female soccer athletes were evaluated using functional magnetic resonance imaging to capture resting-state brain connectivity prior to their competitive season . Two of these athletes later experienced an ACL injury ( ACLI ) . We matched these ACLI participants with eight teammates who did not go on to sustain an ACL injury ( uninjured controls , Con ) based on age , grade , sex , height , and weight to examine differences in preseason connectivity . K Output:	There was no evidence for changes in the CMT . This systematic review is the first to demonstrate evidence that patients with CAI present decreased spinal reflex excitability in the soleus and fibularis longus . However , there is no evidence of changes in supraspinal excitability when considering only the CMT . The latter result needs to be interpreted with caution as all except one study demonstrate some changes at the supraspinal level with CAI
MS2658	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: STUDY DESIGN Systematic review and best evidence synthesis . OBJECTIVES To describe the prevalence and incidence of neck pain and disability in workers ; to identify risk factors for neck pain in workers ; to propose an etiological diagram ; and to make recommendations for future research . SUMMARY OF BACKGROUND DATA Previous review s of the etiology of neck pain in workers relied on cross-sectional evidence . Recently published cohorts and r and omized trials warrant a re- analysis of this body of research . METHODS We systematic ally search ed Medline for literature published from 1980 - 2006 . Retrieved articles were review ed for relevance . Relevant articles were critically appraised . Articles judged to have adequate internal validity were included in our best evidence synthesis . RESULTS One hundred and nine papers on the burden and determinants of neck pain in workers were scientifically admissible . The annual prevalence of neck pain varied from 27.1 % in Norway to 47.8 % in Québec , Canada . Each year , between 11 % and 14.1 % of workers were limited in their activities because of neck pain . Risk factors associated with neck pain in workers include age , previous musculoskeletal pain , high quantitative job dem and s , low social support at work , job insecurity , low physical capacity , poor computer workstation design and work posture , sedentary work position , repetitive work and precision work . We found preliminary evidence that gender , occupation , headaches , emotional problems , smoking , poor job satisfaction , awkward work postures , poor physical work environment , and workers ' ethnicity may be associated with neck pain . There is evidence that interventions aim ed at modifying workstations and worker posture are not effective in reducing the incidence of neck pain in workers . CONCLUSION Neck disorders are a significant source of pain and activity limitations in workers . Most neck pain results from complex relationships between individual and workplace risk factors . No prevention strategies have been shown to reduce the incidence of neck pain in workers Background : Non-specific chronic low back pain disorders have been proven resistant to change , and there is still a lack of clear evidence for one specific treatment intervention being superior to another . Methods : This r and omized controlled trial aim ed to investigate the efficacy of a behavioural approach to management , classification-based cognitive functional therapy , compared with traditional manual therapy and exercise . Linear mixed models were used to estimate the group differences in treatment effects . Primary outcomes at 12-month follow-up were Oswestry Disability Index and pain intensity , measured with numeric rating scale . Inclusion criteria were as follows : age between 18 and 65 years , diagnosed with non-specific chronic low back pain for > 3 months , localized pain from T12 to gluteal folds , provoked with postures , movement and activities . Oswestry Disability Index had to be > 14 % and pain intensity last 14 days > 2/10 . A total of 121 patients were r and omized to either classification-based cognitive functional therapy group n = 62 ) or manual therapy and exercise group ( n > = 59 ) . Results : The classification-based cognitive functional therapy group displayed significantly superior outcomes to the manual therapy and exercise group , both statistically ( p < 0.001 ) and clinical ly . For Oswestry Disability Index , the classification-based cognitive functional therapy group improved by 13.7 points , and the manual therapy and exercise group by 5.5 points . For pain intensity , the classification-based cognitive functional therapy improved by 3.2 points , and the manual therapy and exercise group by 1.5 points . Conclusions : The classification-based cognitive functional therapy produced superior outcomes for non-specific chronic low back pain compared with traditional manual therapy and exercise Musculoskeletal conditions represent a considerable burden worldwide , and are predominantly managed in primary care . Evidence suggests that many musculoskeletal conditions share similar prognostic factors . Systematic ally assessing patient ’s prognosis and matching treatments based on prognostic subgroups ( stratified care ) has been shown to be both clinical ly effective and cost-effective . This study ( Keele Aches and Pains Study ) aims to refine and examine the validity of a brief question naire ( Keele STarT MSK tool ) design ed to enable risk stratification of primary care patients with the five most common musculoskeletal pain presentations . We also describe the subgroups of patients , and explore the acceptability and feasibility of using the tool and how the tool is best implemented in clinical practice . The study design is mixed methods : a prospect i ve , quantitative observational cohort study with a linked qualitative focus group and interview study . Patients who have consulted their GP or health care practitioner about a relevant musculoskeletal condition will be recruited from general practice . Participating patients will complete a baseline question naire ( shortly after consultation ) , plus question naires 2 and 6 months later . A sub sample of patients , along with participating GPs and health care practitioners , will be invited to take part in qualitative focus groups and interviews . The Keele STarT MSK tool will be refined based on face , discriminant , construct , and predictive validity at baseline and 2 months , and vali date d using data from 6-month follow-up . Patient and clinician perspectives about using the tool will be explored . This study will provide a vali date d prognostic tool ( Keele STarT MSK ) with established cutoff points to stratify patients with the five most common musculoskeletal presentations into low- , medium- , and high-risk subgroups . The qualitative analysis of patient and health care perspectives will inform practitioners on how to embed the tool into clinical practice using established general practice IT systems and clinician-support packages Abstract We assessed the effectiveness of a 6-month healthy lifestyle intervention , on pain intensity in patients with chronic low back pain who were overweight or obese . We conducted a pragmatic r and omised controlled trial , embedded within a cohort multiple r and omised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW , Australia . Eligible patients with chronic low back pain ( > 3 months in duration ) and body mass index ≥27 kg/m2 and < 40 kg/m2 were r and omly allocated , using a central concealed r and om allocation process , to receive advice and education and referral to a 6-month telephone-based healthy lifestyle coaching service , or usual care . The primary outcome was pain intensity measured using an 11-point numerical rating scale , at baseline , 2 weeks , and monthly for 6 months . Data analysis was by intention-to-treat according to a prepublished analysis plan . Between May 13 , 2015 , and October 27 , 2015 , 160 patients were r and omly assigned in a 1:1 ratio to the intervention or usual care . We found no difference between groups for pain intensity over 6 months ( area under the curve , mean difference = 6.5 , 95 % confidence interval −8.0 to 21.0 ; P = 0.38 ) or any secondary outcome . In the intervention group , 41 % ( n = 32 ) of participants reported an adverse event compared with 56 % ( n = 45 ) in the control group . Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese , compared with usual care . The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group BACKGROUND AND PURPOSE Patients with hip osteoarthritis have impairments in muscle function ( muscle strength and power ) and hip range of motion ( ROM ) , and it is commonly believed that effective clinical management of osteoarthritis should address these impairments to reduce pain and disability . Therefore , the purpose of this study was to compare the short- and long-term effects of 4 months of physiotherapist-supervised strength training , physiotherapist-supervised Nordic Walking ( NW ) , or unsupervised home-based exercise ( HBE ) on muscle function and hip ROM in patients diagnosed with hip osteoarthritis . METHODS Secondary outcome analyses from an observer-blinded three-armed parallel- design r and omized controlled trial in 60 + -year-old patients with clinical hip osteoarthritis ( American College of Rheumatology criteria ) who were not on a waiting list for hip replacement . One hundred and fifty-two patients were r and omized to either 4 months of physiotherapist-supervised , moderate , progressive , strength training ( n = 50 ) , physiotherapist-supervised NW ( n = 50 ) , or unsupervised HBE ( n = 52 ) . Maximal isometric hip and thigh muscle strength and leg extensor power and active hip ROM were assessed at baseline 2 , 4 , and 12 months . RESULTS Intention-to-treat-analyses did not show any significant between-group differences for improvements in muscle strength and power or ROM at any time points . Short-term significant ( p < .05 ) increases in muscle strength were present in the physiotherapist-supervised exercise groups and in the long-term for muscle power in the NW-group . All exercise modes result ed in significant increases of ROM but long-term improvements were only shown for NW and HBE . DISCUSSION Four months of physiotherapist-supervised , progressive , moderate , and strength training was less effective than hypothesized for improving muscle strength and power in patients with hip osteoarthritis who are not awaiting hip replacement . Our results may indicate that in these patients , improvements in disability are not necessarily dependent on improvements in strength and power or ROM OBJECTIVE To evaluate the effect of training and pain education vs pain education alone , on neck pain , neck muscle activity and postural sway in patients with chronic neck pain . METHODS Twenty women with chronic neck pain were r and omized to receive pain education and specific training ( neck-shoulder exercises , balance and aerobic training ) ( INV ) , or pain education alone ( CTRL ) . Effect on neck pain , function and Global Perceived Effect ( GPE ) were measured . Surface electromyography ( EMG ) was recorded from neck flexor and extensor muscles during performance of the Cranio-Cervical Flexion Test ( CCFT ) and three postural control tests ( two-legged : eyes open and closed , one-legged : eyes open ) . Sway parameters were calculated . RESULTS Fifteen participants ( CTRL : eight ; INV : seven ) completed the study . Per protocol analyses showed a larger pain reduction ( p = 0.002 ) for the INV group with tendencies for increased GPE ( p = 0.06 ) , reduced sternocleidomastoid activity during the CCFT ( p = 0.09 ) , reduced sway length ( p = 0.09 ) , and increased neck extensor activity ( p = 0.02 ) during sway compared to the CTRL group . CONCLUSION Pain education and specific training reduce neck pain more than pain education alone in patients with chronic neck pain . These results provide encouragement for a larger clinical trial to corroborate these observations Background Disturbed sleep and pain often co-exist and the relationship between the two conditions is complex and likely reciprocal . This 5-year prospect i ve study examines whether disturbed sleep can predict the onset of multi-site pain , and whether non-disturbed sleep can predict the resolution of multi-site pain . Methods The cohort ( n = 1599 ) was stratified by the number of self-reported pain sites : no pain , pain from 1–2 sites and multi-site pain ( ≥3 pain sites ) . Sleep was categorized by self-reported sleep disturbance : sleep A ( best sleep ) , sleep B and sleep C ( worst sleep ) . In the no-pain and pain-from-1–2 sites strata , the association between sleep ( A , B and C ) and multi-site pain 5 years later was analysed . Further , the prognostic value of sleep for the resolution of multi-site pain at follow-up was calculated for the stratum with multi-site pain at baseline . In the analyses , gender , age , body mass index , smoking , physical activity and work-related exposures were treated as potential confounders . Results For individuals with no pain at baseline , a significantly higher odds ratio for multi-site pain 5 years later was seen for the tertile reporting worst sleep [ odds ratio ( OR ) 4.55 ; 95 % confidence interval ( CI ) 1.28–16.12 ] . Non-disturbed ( or less disturbed ) sleep had a significant effect when predicting the resolution of multi-site pain ( to no pain ) ( OR 3.96 ; 95 % CI 1.69–9.31 ) . Conclusion In conclusion , sleep could be relevant for predicting both the onset and the resolution of multi-site pain . It seems to be a significant factor to include in research on multi-site pain and when conducting or evaluating intervention programmes for pain & NA ; An association is demonstrated between genetic polymorphisms in the gene coding for a key regulatory molecule in the hypothalamic‐pituitary‐adrenal axis and persistent pain after trauma . & NA ; Individual vulnerability factors influencing the function of the hypothalamic‐pituitary‐adrenal axis may contribute to the risk of the development of persistent musculoskeletal pain after traumatic stress exposure . The objective of the study was to evaluate the association between polymorphisms in the gene encoding FK506 binding protein 51 , FKBP5 , a glucocorticoid receptor co‐chaperone , and musculoskeletal pain severity 6 weeks after 2 common trauma exposures . The study included data from 2 prospect i ve emergency department‐based cohorts : a discovery cohort ( n = 949 ) of European Americans experiencing motor vehicle collision and a replication cohort of adult European American women experiencing sexual assault ( n = 53 ) . DNA was collected from trauma survivors at the time of initial assessment . Overall pain and neck pain 6 weeks after trauma exposure were assessed using a 0–10 numeric rating scale . After adjustment for multiple comparisons , 6 FKBP5 polymorphisms showed significant association ( minimum P < 0.0001 ) with both overall and neck pain in the discovery cohort . Output:	The results of this review found that the strongest treatment effects to date are those associated with exercise . Strengthening exercises of the neck and upper quadrant have a moderate effect on neck pain in the short-term . Lower quality evidence and smaller effects were found for other exercise approaches . Other treatments , including education/advice and psychological treatment , showed only very small to small effects , based on low to moderate quality evidence .
MS2659	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Children with asthma who live in the inner city are exposed to multiple indoor allergens and environmental tobacco smoke in their homes . Reductions in these triggers of asthma have been difficult to achieve and have seldom been associated with decreased morbidity from asthma . The objective of this study was to determine whether an environmental intervention tailored to each child 's allergic sensitization and environmental risk factors could improve asthma-related outcomes . METHODS We enrolled 937 children with atopic asthma ( age , 5 to 11 years ) in seven major U.S. cities in a r and omized , controlled trial of an environmental intervention that lasted one year ( intervention year ) and included education and remediation for exposure to both allergens and environmental tobacco smoke . Home environmental exposures were assessed every six months , and asthma-related complications were assessed every two months during the intervention and for one year after the intervention . RESULTS For every 2-week period , the intervention group had fewer days with symptoms than did the control group both during the intervention year ( 3.39 vs. 4.20 days , P<0.001 ) and the year afterward ( 2.62 vs. 3.21 days , P<0.001 ) , as well as greater declines in the levels of allergens at home , such as Dermatophagoides farinae ( Der f1 ) allergen in the bed ( P<0.001 ) and on the bedroom floor ( P=0.004 ) , D. pteronyssinus in the bed ( P=0.007 ) , and cockroach allergen on the bedroom floor ( P<0.001 ) . Reductions in the levels of cockroach allergen and dust-mite allergen ( Der f1 ) on the bedroom floor were significantly correlated with reduced complications of asthma ( P<0.001 ) . CONCLUSIONS Among inner-city children with atopic asthma , an individualized , home-based , comprehensive environmental intervention decreases exposure to indoor allergens , including cockroach and dust-mite allergens , result ing in reduced asthma-associated morbidity Background : It is not clear whether associations between respiratory symptoms and indoor mould are causal . A r and omised controlled trial was conducted to see whether asthma improves when indoor mould is removed . Methods : Houses of patients with asthma were r and omly allocated into two groups . In one group , indoor mould was removed , fungicide was applied and a fan was installed in the loft . In the control group , intervention was delayed for 12 months . Question naires were administered and peak expiratory flow rate was measured at baseline , 6 months and 12 months . Results : Eighty-one houses were allocated to the intervention group and 83 to the control group ; 95 participants in 68 intervention houses and 87 in 63 control houses supplied follow-up information . Peak expiratory flow rate variability declined in both groups , with no significant differences between them . At 6 months , significantly more of the intervention group showed a net improvement in wheeze affecting activities ( difference between groups 25 % , 95 % CI 3 % to 47 % ; p = 0.028 ) , perceived improvement of breathing ( 52 % , 95 % CI 30 % to 74 % ; p<0.0001 ) and perceived reduction in medication ( 59 % , 95 % CI 35 % to 81 % ; p<0.0001 ) . By 12 months the intervention group showed significantly greater reductions than the controls in preventer and reliever use , and more improvement in rhinitis ( 24 % , 95 % CI 9 % to 39 % ; p = 0.001 ) and rhinoconjunctivitis ( 20 % , 95 % CI 5 % to 36 % ; p = 0.009 ) . Conclusions : Although there was no objective evidence of benefit , symptoms of asthma and rhinitis improved and medication use declined following removal of indoor mould . It is unlikely that this was entirely a placebo effect Objective Home dampness and the presence of mold and allergens have been associated with asthma morbidity . We examined changes in asthma morbidity in children as a result of home remediation aim ed at moisture sources . Design In this prospect i ve , r and omized controlled trial , symptomatic , asthmatic children ( n = 62 ) , 2–17 years of age , living in a home with indoor mold , received an asthma intervention including an action plan , education , and individualized problem solving . The remediation group also received household repairs , including reduction of water infiltration , removal of water-damaged building material s , and heating/ventilation/air-conditioning alterations . The control group received only home cleaning information . We measured children ’s total and allergen-specific serum immuno-globulin E , peripheral blood eosinophil counts , and urinary cotinine . Environmental dust sample s were analyzed for dust mite , cockroach , rodent urinary protein , endotoxin , and fungi . The follow-up period was 1 year . Results Children in both groups showed improvement in asthma symptomatic days during the preremediation portion of the study . The remediation group had a significant decrease in symptom days ( p = 0.003 , as r and omized ; p = 0.004 , intent to treat ) after remodeling , whereas these parameters in the control group did not significantly change . In the postremediation period , the remediation group had a lower rate of exacerbations compared with control asthmatics ( as treated : 1 of 29 vs. 11 of 33 , respectively , p = 0 . 003 ; intent to treat : 28.1 % and 10.0 % , respectively , p = 0.11 ) . Conclusion Construction remediation aim ed at the root cause of moisture sources and combined with a medical/behavioral intervention significantly reduces symptom days and health care use for asthmatic children who live in homes with a documented mold problem Exposure to house‐dust mites ( Dermatophagoides spp . ) was investigated in 30 asthmatic patients before and after moving to homes with mechanical ventilation systems . Median house‐dust mite concentration was 110 mites per gram of mattress dust at the initial investigation and 20 mites per gram at the first follow‐up after a mean of 4.7 months in the new homes . This was lower ( P < 0.05 ) than counts in a control group of 23 asthmatic patients that had unchanged counts . At a second follow‐up , after 15.0 months , mite counts in the study group were further reduced ( P < 0.01 ) from initial values . Among 16 patients , with initial mite counts above the recommended threshold limit value ( TLV ) of 100 mites per gram of dust , the mite counts fell , in most cases , below this TLV . Air‐exchange rates increased ( P < 0.001 ) from a median value of 0.40 air changes per hour ( ach ) to 1.52 ach at the second follow‐up investigation . Furthermore , a reduction ( P < 0.01 ) was found in indoor absolute air humidity , with a median value of 5.6 g of water/kg . No such changes were found in the control group . The present study indicates that reduction of air humidity through an increased supply of fresh air may significantly diminish and , in some cases , even eliminate house‐dust mites in homes To evaluate the effect of a room high-efficiency particulate air ( HEPA ) cleaner on cat-induced asthma and rhinitis , 35 cat-allergic subjects who were living with one or more cats were studied in a double-blind , placebo controlled trial . After a 1 mo baseline period , subjects ' bedrooms were equipped with an active or placebo air cleaner for the following 3 mo . Evaluations included monthly measurement of cat-allergen levels , daily morning , afternoon , and nighttime nasal- and chest-symptom scores , twice-daily measurement of peak-flow rates , daily medication scores , monthly spirometry , and methacholine ( MCh ) challenge testing before and after the study . Airborne allergen levels were reduced in the active-filter group as compared with the placebo group ( p = 0.045 ) . However , no differences were detected in settled-dust allergen levels ( p = 0.485 ) , morning , afternoon , or nighttime nasal-symptom scores ( p = 0.769 , 0.534 , and 0.138 ) , chest-symptom scores ( p = 0.388 , 0.179 , and 0.215 ) , sleep disturbance ( p = 0.101 ) , morning or afternoon peak-flow rates ( p = 0 . 424 and 0.679 ) , or rescue medication use ( nasal , p = 0.164 , chest , p = 0.650 ) , respectively . Although the combination of a HEPA room air cleaner , mattress and pillow covers , and cat exclusion from the bedroom did reduce airborne cat-allergen levels , no effect on disease activity was detected for any parameter studied This study looked at the influence of inspired air water content on exercise-induced bronchospasm ( EIB ) . On separate days , 12 mild asthmatics ( 4 M , 8F ) , aged 18 - 39 yrs ( mean : 27 yrs ) , performed four six minute steady-state exercises on ergometer at 80 % of their maximum workload . Exercises were r and omized to the following inspired air conditions : dry air ( 0 % relative humidity ( RH ] during exercise followed by dry ( DD ) or humid air ( 100 % RH ) ( DH ) after exercise , humid air during exercise followed by dry ( HD ) or humid air ( HH ) . Room temperature was kept constant ( 22 + /- 1 degree C ) at all visits . Forced expiratory volume in one second ( FEV1 ) was measured before and every 5 min for 25 min after exercise . Ventilation ( VE ) was not significantly different whether the exercise was done under dry or humid air . There was a residual bronchodilatation at the end of exercises performed in humid air , while at this time FEV1 was already lower than baseline when exercise was done in dry air conditions . The maximal fall in FEV1(% ) following exercise was significantly greater after those performed in dry air : DD ( 29 + /- 5.6 % ) and DH ( 30 + /- 5.8 % ) than in humid air : HD ( 12 + /- 4.9 % ) and HH ( 20 + /- 4.9 % ) ( p less than 0.05 ) . The time-course of recovery from bronchoconstriction was significantly improved when inhaling dry air after exercise . However , the difference found in the maximal % fall in FEV1 after exercise when recovery was in dry compared to humid air did not achieve statistical significance . In conclusion , EIB is influenced by the changes in water content during and after exercise . Bronchoconstriction following exercise is minimal if exercise is done in humid air and recovery in dry air , and maximal if the exercise is performed in dry air and recovery in humid air We have examined the effect of reducing relative humidity ( RH ) , with inbuilt mechanical ventilation and heat‐exchange ( MVHE ) units , on house‐dust‐ mite ( HDM ) counts and allergen levels , in a pilot study of 10 Wellington dwellings . Recent international prevalence studies in adults and children have confirmed a high prevalence of asthma in New Zeal and , Sensitivity to HDM is common among the general population , and HDM is the major allergen associated with asthma . Recent studies of allergen levels have confirmed high concentrations of Der p 1 in the domestic environment . While humidity was significantly reduced in those dwellings fitted with ventilation units , no systematic effect on mites or Der p 1 was observed during the study period . When the reductions in humidity were examined in the context of the time spent below the critical equilibrium humidity ( CEH ) , the intervention led to RH values below the CEH for only 39 % of the total of 24‐h periods for which measurements were made . Reducing RH by means of MVHE in New Zeal and domestic dwellings does not lower humidity sufficiently , or long enough , to have any measurable effect on HDM population To evaluate the effect of preventive measures 46 patients , all allergic to house‐dust mites ( Dermatophagoides spp . ) , were r and omly allocated to a study and a control group . According to the patients ' subjective recordings of symptom score and use of medicine , compared with the control group , the study group had improved . There was , however , no improvement when comparing the objective recordings of morning and evening peak flow and use of medicine , and it is concluded that the preventive measures in this programme are not very effective for patients allergic to house‐dust mites . The reduction in indoor humidity in the study group was limited and , as a high indoor humidity is the cause of huge population s of house‐dust mites in homes , it is emphasized that future programmes of preventive measures should focus more on damp problems , particularly those related to bad housing construction BACKGROUND The relationship between exposure to house dust mite ( HDM ) allergens and prevalence of sensitization to these allergens in patients with asthma has been confirmed in many studies . Mite population growth is regulated by humidity . Reducing humidity and removing allergen by efficient vacuuming should control mite allergen and reduce symptoms . OBJECTIVE We sought to investigate the effect of mechanical ventilation and high-efficiency vacuuming on HDM numbers and Der p 1 concentrations in the homes of mite-sensitive asthmatic subjects and to evaluate the effect of any reductions on symptoms . METHODS The homes of 40 HDM-sensitive asthmatic subjects were r and omized to receive ( 1 ) mechanical ventilation and a high-efficiency vacuum cleaner ( HEVC ) ; ( 2 ) mechanical ventilation alone ; ( 3 ) an HEVC alone ; and ( 4 ) Output:	There was no significant difference in quality of life , rescue medication , requirement for oral corticosteroids , visits to the GP , emergency department ( ED ) or hospitalisations for asthma . There was no significant difference in the house dust mite count and the antigen levels in the new trial , in contrast to the previous trial . Evidence on clinical benefits of dehumidification using mechanical ventilation with dehumidifiers remains scanty , and the addition of a new double blind trial to this review does not indicate significant benefit in most measure of control of asthma from such environmental interventions
MS2660	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Since 1971 , 82 patients with advanced carcinoma of the cervix have been included in a r and omised clinical trial in association with the Working Party on Radiotherapy and Hyperbaric Oxygen of the Medical Research Council . External irradiation was given in 10 fractions by an unconventional schedule , either in air or HBO , and combined with three large fractions of intracavitary irradiation using the Cathetron . The results are acceptable overall , with 69 % local control , 15 % with tumour developing outside the treated volume and 40 % survival at five years , but no improvement has been shown with HBO . Symptoms suggestive of some degree of late damage to the small bowel were present in 13 % of patients , with a higher but not statistically significant , incidence in the HBO group . It is postulated that the schedule of radiotherapy used has allowed reoxygenation during treatment and that no further gain due to the use of HBO may be achieved . After a review of the results from other centres and taking into account the difficulties of treatment in HBO it is concluded that for advanced carcinoma of the cervix the addition of HBO to radiotherapy is not clinical ly worthwhile BACKGROUND AND PURPOSE A r and omised controlled trial of hyperbaric oxygen in the radiotherapy of Stage IIb and III carcinoma of cervix was performed between 1971 and 1980 . Apart from an abstract giving an interim report in 1977 , results have not been published . MATERIAL AND METHODS In a four arm study , 335 patients were r and omised to treatment in 10 or 28 fractions , in hyperbaric oxygen or in air . Data is available concerning 327 cases and this has been analysed . RESULTS There was no advantage in tumour control shown with the use of hyperbaric oxygen . There was evidence for an increase in late radiation morbidity when treatment was given in hyperbaric oxygen rather than in air and when , using 10 fractions , a total dose of 45 rather than 40 Gy was achieved . For late intestinal morbidity , the fractionation sensitivity ( alpha/beta ratio ) was calculated to be 4.3 Gy and the steepness of the dose response curve ( gamma50 ) to be 2.6 . CONCLUSIONS Hyperbaric oxygen gave no benefit in the treatment of patients with stage IIb and III carcinoma of the cervix treated with radiotherapy using two fractionation regimes . Important data regarding late radiation morbidity has been revealed The 15 r and omised controlled clinical trials of hyperbaric oxygen in radiotherapy yielded three with highly significant benefit and six with useful margins not reaching statistical significance . The increase in tumour control was partly negated by an increase in normal tissue effect . Now simple carbogen breathing in animal tumour models has shown high efficiency and there is the potential for its use in man as a simple means of hypoxic cell radiosensitization Abstract In controlled trials using the hyperbaric oxygen chamber in the radiotherapy of carcinoma of the bladder , no benefit was found in a series of 40 patients treated using 30 fractions and a total dose of 6,000 R and in a series of 27 patients treated using 15 fractions and a total dose of 4,725R . In an uncontrolled trial in advanced cases using six fractions and a maximum tissue dose of 3,600 R results seemed improved despite the selection of cases . A new trial comparing this six-fraction technique with multiple fractions in air is now being carried out . Similar trials are being performed in a number of radiotherapy centres and it is planned to pool results so as to obtain a significant result at an early time . In the work reported , doses have been quoted in R units ; the absorbed dose can be obtained by multiplying stated values by 0·97 A controlled clinical trial is in progress to assess the value of hyperbaric oxygen and radiotherapy in the management of head and neck cancer . An established dose-fractionation schedule in hyperbaric oxygen is being compared with a widely used conventional schedule in air . Survival and local recurrence-free rates are significantly higher in the oxygen group , and the effects on normal tissue are similar in both groups . These findings suggest a genuine therapeutic advantage . There was a distinct improvement in the results of treating advanced laryngeal carcinoma , where there was a high survival rate , without resort to laryngectomy This is an interim report of a clinical trial of radiotherapy of advanced oropharyngeal cancer under hyperbaric oxygenation . Fifty-one cases are available for evaluation , 26 in the oxygen group , 12 in the Control Group I , and 13 in the Control Group II.The results are analyzed as to : ( 1 ) clearance rates of the primary tumor , in which a 23 per cent higher clearance rate for the primary tumor in the oxygen group than in the air Control Group I is noted ; ( 2 ) survival rates , in which a 13 - 15 per cent increase of the 5 year survival is revealed in the oxygen group , compared to the air Control Group I ; and ( 3 ) complication rates and incidence of distant metastases which are not higher in the oxygen group than in the control groups . Although the difference of local tumor clearance and the survival rates between the oxygen and the control groups are not statistically significant due to the small sample size , the evidence of improvement in both local tumor clearance and in survival rates from our series and from tha Twenty-seven patients with carcinoma of the bladder were treated at the Glasgow Institute of Radiotherapeutics as part of a national hyperbaric oxygen trial . These patients were treated on a 4 MeV linear accelerator either in air or in 3 atm , absolute , of oxygen , by r and om selection . Of these patients , one-third were found to have high-dose effects to an extent which necessitated surgery . No association was found between the incidence of high-dose effects and treatment in air or hyperbaric oxygen . The treatment protocol used in all cases was to give an intended modal tumour dose of 6000 rad in 24 fractions in approximately 5 weeks . As all patients had received the same modal dose , there was no apparent reason why some had developed high-dose effects . However , on the basis of a Cumulative Radiation Effect ( CRE ) analysis of the treatment regimes given , a close correlation was found between the maximum CRE achieved and the occurrence of high-dose effects . Above a threshold level of 1910 reu in the maximum CRE achieved , there was a high incidence and rapid onset of high-dose effects . The reasons for the occurrence of the exceptionally high CRE values found in some patients are discussed . From a review of clinical results of bladder treatments , it is apparent that at a CRE level of 1910 reu , the tumour control rate is still increasing with CRE . It is proposed that by choosing the dose given on any treatment schedule to keep the maximum value of the CRE achieved just below 1910 reu , the greatest probability of cure would be obtained with minimum complication rate Abstract An interim report is given of a r and omized controlled trial of hyperbaric oxygen in the treatment of carcinoma of the cervix . A total of 82 patients with late Stage II , Stage III and early Stage IV disease were included between January 1966 and June 1971 . A minimum tumour dose of 5,500 R was given to the pelvis , either in oxygen or in air , in 27 treatments over 37 days and was followed by a radium application . An assessment of the results in 77 cases is presented . Seventy per cent of patients treated in oxygen were alive and free from disease at one year and this compared with 50 per cent of the patients treated in air . The difference was not statistically significant and became less until the results were the same at three years . In the early years after treatment the local failure rate in oxygen cases was less than in air , but was not statistically significant . There is a significant correlation between the clinical and histological assessment of regression at the end of treatment and subsequen In a r and omized controlled clinical trial of hyperbaric oxygen in the radiotherapy of advanced carcinoma of the uterine cervix a total of 320 cases were contributed by four radiotherapy centres in the United Kingdom . The use of hyperbaric oxygen result ed in improved local control and survival . The benefit was greatest in patients under the age of 55 who presented with stage III disease . There was a slight increase in radiation morbidity but it seemed that the benefit of hyperbaric oxygen outweighed this increase in morbidity and that there was a true improvement in the therapeutic ratio We report the results of a prospect i ve controlled trial of the effect of hyperbaric oxygen as an adjuvant in radiotherapy of head and neck cancer . Patients were allocated r and omly to treatment in oxygen or air . The radiotherapy in both groups was identical in planning , dose , and fractionation -- i.e . , 3500 rads in 10 fractions in 3 weeks . There was no difference in the survival rate between the two groups . However , significantly better local tumour control was seen in the hyperbaric-oxygen group , particularly in smaller lesions ; there was significantly greater need for salvage surgery in the air group . Radiation effects on normal tissue appeared somewhat greater in the oxygen series , especially on laryngeal cartilage One hundred and thirty patients with locally advanced squamous carcinoma of the head and neck were treated in a prospect i ve r and omized trial to compare conventional irradiation ( 63.00 Gy in 30 fractions ) with a combination sensitizer regimen of misonidazole and hyperbaric oxygen . The drug ( 2.0 gm/m2 ) was given with each of six fractions of 6.0 Gy in hyperbaric oxygen at 3 ATA . The results support a previous study and favor the combination at 1 year at better than the 10 % level . This regimen could be useful for bulky primary or nodal disease The clinical trials of the use of hyperbaric oxygen in radiotherapy conducted by the Medical Research Council 's working party have shown that local cure and survival can be improved in head and neck and cervical cancer . Evidence for benefit has been presented in carcinoma of bronchus , but none has so far been found in carcinoma of the bladder . Although hyperbaric oxygen has produced increased effect upon normal tissues as well as upon tumour , a real improvement in therapeutic ratio appears to be present . The future use of hyperbaric oxygen in radiotherapy will depend upon a comparison of effectiveness with other methods now being tested to improve radiotherapy . The trials have yielded much fundamental and clinical data of general relevance in the radiotherapy of malignant disease Abstract A prospect i ve clinical trial has been established design ed to evaluate the role of hyperbaric oxygen in the treatment of patients with Stages 2b and 3 carcinoma of the cervix . Three Cathetron fractions using a line source , plus ten fractions of high energy external irradiation either in air or hyperbaric oxygen are given to the whole of the defined tumour volume . Details concerning the method of treatment adopted are presented and discussion of the problems involved . So far , 45 patients have been included and the preliminary results lend encouragement to the continuation of the overall treatment method irrespective of any possible benefits of hyperbaric oxygen which may appear in the long term Follow-up data at five years are reported for 24 patients with squamous cell carcinoma of the head and neck , included in a r and omised prospect i ve MRC study of radiotherapy in hyperbaric oxygen ( 10 fractions ) or air ( 15 or 20 fractions ) . Although few , the data show a significant gain in local control ( P less than 0.001 ) and survival ( P less than 0.05 ) with the use of hyperbaric oxygen but no increased tissue reactions or morbidity In a r and omized controlled clinical trial of hyperbaric oxygen in the radiotherapy of carcinoma of the bladder a total of 241 cases were contributed by four radiotherapy centres in the United Kingdom . In this trial where in each centre identical radiotherapy was employed for both oxygen and air cases , no benefit was shown with the use of hyperbaric oxygen Abstract A r and omized study of squamous cell carcinoma of the head and neck , with the exception of T , vocal cord lesions , compared 23 patients who were treated in air with doses of 250 rad four times a week to 6250 rad , to 21 patients who were treated at three atmospheres of hyperbaric oxygen with 12 x 400-rad fractions in approximately 32 days . Distribution by anatomic site and age were comparable . Distribution by stage was in favor of the air group since five Stage I patients were found in the air group but none in the hyperbaric oxygen group . The sex distribution was uneven-15 males to eight females in the air group and eight males to 13 females in the oxygen group . All patients were followed for a minimum of two years ; most patients were followed more than five years , with indefinite followup . The 12 × 400-rad schedule in four and one-half weeks in the hyperbaric oxygen group proved to be well tolerated without any significant increase in complications . Radiation myelitis can be avoided by limiting the spinal cord dose to 7 × 400 rad It is now well established that most animal solid tumors contain oxygen-deficient hypoxic cells and that these cells will influence the response of those tumors to radiation . Identifying hypoxic cells in human tumors has proven more difficult , primarily because most of the direct procedures used in animals are not applicable to humans . However , substantial indirect evidence , which goes back to as early as 1909 , clearly indicates the presence of hypoxia in human tumors , although with a considerable heterogeneity among individual tumors . Experimental studies during the last 30 years have shown that this source of radiation resistance can be effectively eliminated by a variety of procedures that include high oxygen-content gas breathing , nitrometric radiation sensitizers , blood transfusions , hemoglobin-oxygen affinity modifiers , and nicotinamide . A number of these procedures have also been tested clinical ly such that by 1995 over 10,000 patients in 83 r and omized trials had undergone treatment design ed to modify tumor hypoxia before radiation therapy . Although a number of these trials showed no benefit , an overview analysis showed that modification Output:	The effect of HBOT varied with different fractionation schemes . Any advantage is achieved at the cost of some adverse effects . AUTHORS ' CONCLUSIONS There is some evidence that HBOT improves local tumour control and mortality for cancers of the head and neck , and local tumour recurrence in cancers of the head and neck , and uterine cervix . These benefits may only occur with unusual fractionation schemes . HBOT is associated with significant adverse effects including oxygen toxic seizures and severe tissue radiation injury .
MS2661	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective : To describe NP and AOM otopathogens during the time frame 2007 to 2009 , 6 to 8 years after the introduction of 7-valent pneumococcal conjugate ( PCV7 ) in the United States and to compare nasopharyngeal ( NP ) colonization and acute otitis media ( AOM ) microbiology in children 6 to 36 months of age having first and second AOM episodes with children who are otitis prone . Methods : Prospect ively , the microbiology of NP colonization and AOM episodes was determined in 120 children with absent or infrequent AOM episodes . NP sample s were collected at 7 routine visits between 6 and 30 months of age and at the time of AOM . For first and subsequent AOM episodes , middle ear fluid ( MEF ) was obtained by tympanocentesis . Eighty otitis prone children were comparatively studied . All 200 children received age-appropriate doses of PCV7 . Results : We found PCV7 serotypes were virtually absent : ( 0.9 % isolated from both NP and MEF ) in both study groups . However , non-PCV7 serotypes replaced PCV serotypes such that the frequency of isolation of S. pneumoniae ( Spn ) was nearly equal to that of non-typeable Haemophilus influenzae ( NTHi ) . M. catarrhalis ( Mcat ) was less common and Staphylococcus aureus infrequent in the NP and MEF from the 2 groups . The proportion of Spn , NTHi and Mcat causing AOM was similar in children with first and second AOM episodes compared to otitis prone children . However , oxacillin-resistant Spn isolated from the NP and MEF was 19 % for the absent/infrequent and 58 % for the otitis prone groups , P < 0.0001 . Beta-lactamase producing NTHi occurred more frequently in the otitis prone group , P = 0.04 . Conclusions : Six to 8 years after widespread use of PCV7 , Spn strains expressing vaccine-type serotypes have virtually disappeared from the NP and MEF of vaccinated children . NP colonization and AOM has changed to non-PCV7 strains of Spn . NTHi continues to be a major AOM pathogen . The otopathogens in first and second AOM and in otitis prone children are very similar although Spn and NTHi are more often antibiotic resistant in the otitis prone A prospect i ve cohort study was conducted to analyze factors associated with antibiotic noncompliance and waste among patients suffering acute respiratory infection ( ARI ) and acute diarrhea ( AD ) . The study took place in four primary health care clinics in Mexico City , two belonging to the Ministry of Health ( MoH ) and two to the Mexican Social Security Institute ( IMSS ) . Two hundred twenty-two patients with ARI and 155 with AD were included . Data about study variables and the assessment of compliance were obtained through patient interviews and direct observation . Factors associated with noncompliance were assessed through a multiple logistic regression procedure . Noncompliance was 60 % for ARI and 55.5 % for AD in both health care systems . Prescription of an antibiotic was justified only in 13.5 % of cases . Associated factors were : increased duration of illness ( OR 2.95 ; 95 % CI , 1.17 - 7.41 ) ; complexity of the treatment : 3 or more doses per day ( OR 2.47 ; 95 % CI , 1.56 - 3.92 ) , and treatment for more than 7 days ( OR 1.94 ; 95 % CI , 1.16 - 3.26 ) ; younger age of patient ( OR 1.89 ; 95 % CI , 1.18 - 3.02 ) ; and an inadequate physician-patient relationship ( OR 1.87 ; 95 % CI , 1.16 - 3.02 ) . Antibiotic waste was higher in IMSS ( ARI 39.3 % , AD 32.6 % ) , than in the MoH ( ARI 21.2 % , AD 16.4 % ) . Educational strategies to modify physician prescribing practice s and strengthen physician-patient relationships might improve compliance and decrease drug waste The treatment of streptococcal pharyngitis with azithromycin ( 10 mg/kg orally once daily for 3 days ) or clarithromycin ( 7.5 mg/kg orally twice daily for 10 days ) was compared in a r and omized observer-blind study carried out in 174 children with documented Streptococcus pyogenes infection . The observed cure rate 10 days after the beginning of treatment was 61/63 ( 96.8 % ) in the clarithromycin group and 71/74 ( 95.9 % ) in the azithromycin group . At days 17 – 20 the bacteriological eradication rate was 95.2 % for clarithromycin and 94.6 % for azithromycin . When children who did not complete treatment were included in the analysis the eradication rate was higher for azithromycin ( 93.6 % compared with 82.9 % ; P < 0.05 ) ; the difference was due to better compliance with the azithromycin regimen The usefulness of clinical and laboratory findings for prediction of the presence of Group A streptococci on throat culture and of an increase in antistreptococcal antibodies was investigated in 693 adult patients . Several findings were shown to increase the likelihood of streptococcal isolation , alone and in combination : tonsillar exu date , tonsillar enlargement , tender anterior cervical adenopathy , myalgias , and a positive throat culture in the preceding year . Compared with a frequency of 9.7 % in all patients , the probabilities of a positive culture were quite different ( ranging from 2 to 53 % ) in subgroups of patients with different combinations of these clinical findings . The results of a leukocyte count and measurement of C-reactive protein added little additional predictive information . While clinical findings can never predict perfectly the results of a throat culture , they nevertheless can provide useful information — particularly in tending to “ rule out ” streptococcal infection — in adult patients with pharyngitis The safety and efficacy of clarithromycin was compared with those of amoxicillin-potassium calvulanate for the treatment of acute otitis media in children . In a multicenter , r and omized , investigator-blinded trial , 180 patients ( 6 months to 12 years of age ) with acute otitis media were allocated to receive either clarithromycin , 15 mg/kg in two divided doses ( n = 90 ) , or amoxicillin-clavulanate , 40 mg/kg in three divided doses ( n = 90 ) , for 10 days . Middle ear sample s were obtained by tympanocentesis from 175 of 180 patients . Pathogens were isolated from 137 sample s ( 76 % ) . Eighty-six patients in each treatment group were considered for efficacy analysis . Clinical cure or improvement was achieved within 4 days after treatment in 80 ( 93 % ) of 86 patients receiving clarithromycin and in 82 ( 95 % ) of 86 patients receiving amoxicillin-clavulanate . Recurrence of infection was observed between 5 and 35 days after treatment in 9 ( 11 % ) of 80 patients in the clarithromycin group and in 8 ( 10 % ) of 82 patients in the amoxicillin-clavulanate group . Middle ear effusion was found with similar frequency at the end of therapy and at follow-up visits in both treatment groups . Mild gastrointestinal signs and symptoms , the most common side effects , were noted in 20 % and 52 % of patients in the clarithromycin group and the amoxicillin-clavulanate group , respectively ( p < 0.001 ) . We conclude that clarithromycin is a safe and effective antimicrobial agent for the treatment of acute otitis media in children & NA ; The safety and efficacy of a new oral suspension formulation of clarithromycin were evaluated in this multicenter , Phase III , single blind , comparative trial in 379 children ages 6 months to 12 years with signs or symptoms of acute otitis media . Children were r and omized to receive a 10‐day course of clarithromycin oral suspension ( 7.5 mg/kg ; maximum , 500 mg ) or cefaclor oral suspension ( 20 mg/kg ; maximum , 500 mg ) twice daily . Specific clinical response criteria were developed based on pretreatment signs and symptoms and results of tympanometry . Of the 379 enrolled patients 281 ( 74 % ) were evaluable ( clarithromycin , 150 ; cefaclor , 131 ) . There were no demographic differences between the two groups . Fifty percent of the patients had 2 to 4 episodes of otitis media ( including the current episode ) in the past 12 months ; 63 % of the patients had an infection of moderate severity . Clarithromycin and cefaclor suspensions were similarly effective for the treatment of acute otitis media . Clinical success ( cure , cure with effusion or improvement ) was achieved in 86 % of clarithromycin‐treated patients and 90 % of cefaclor‐treated patients . The majority of bacterial isolates for which susceptibility results were available were fully or moderately susceptible to the study drugs ( 96 % clarithromycin , 92 % cefaclor ) . Both drugs were welltolerated ; adverse events considered probably study drug‐related were reported by 30 ( 15 % ) of clarithromycin recipients and 31 ( 17 % ) of cefaclor recipients . There were no significant differences between the groups in the numbers of patients reporting events that were thought to be related to study medication . A 10‐day regimen of clarithromycin suspension ( 7.5 mg/kg twice daily ) appears to be as safe and effective as a 10‐day regimen of cefaclor suspension ( 20 mg/kg twice daily ) for the treatment of acute otitis media in children Objective . To compare the safety and efficacy of a short course ( 5 days ) of ceftibuten vs. azithromycin for 3 days for treatment of group A beta-hemolytic streptococcal ( GABHS ) pharyngitis in children . Methods . A multicenter , open label , prospect i ve , r and omized trial in which patients ≥3 to ≤16 years of age with proven GABHS pharyngitis were r and omized to receive either once daily ceftibuten for 5 days or azithromycin for 3 days . Patients were evaluated for clinical outcomes and /or for adverse events at days 6 to 8 , 13 to 15 and 33 to 35 posttherapy . Microbiologic assessment s ( pharyngeal cultures ) were conducted at baseline and at each follow-up visit . Results . A total of 132 patients in the ceftibuten arm and 116 in the azithromycin arm were enrolled in the safety analysis , whereas 126 and 101 , respectively , were enrolled for ceftibuten and azithromycin efficacy evaluation . Clinical success ( cure or marked amelioration ) at days 6 to 8 was recorded in 98 and 94 % in the 2 groups , respectively . In the bacteriologic efficacy analysis at 6 to 8 days , the GABHS strain was eradicated in 76 % of the patients treated with ceftibuten and in 76 % of those receiving azithromycin . At 33 to 35 days , 84 % of the patients in the ceftibuten arm and 71 % in the azithromycin arm were GABHS-negative , and bacteriologic relapse was observed in 4 and 7 % of the ceftibuten and azithromycin cases , respectively . Both treatments were well-tolerated by all patients . Conclusions . Ceftibuten and azithromycin allow simple treatment schedules ( i.e. once daily administration , short duration of treatment ) . The somewhat higher eradication rate recorded after ceftibuten administration is consistent with the overall superior bactericidal activity of beta-lactams compared with macrolides vs. GABHS in vitro Background : Short course antimicrobial therapy is suggested for group A streptococcal tonsillopharyngitis . Methods : The bacteriologic and clinical efficacies of clarithromycin [ 30 or 15 mg/kg/day twice daily ( b.i.d . ) ] or amoxicillin/clavulanate ( 43.8/6.2 mg/kg/day b.i.d . ) for 5 days or penicillin V ( 30 mg/kg/day 3 times a day ) for 10 days were compared . In a r and omized , open label , parallel group , multicenter study , 626 children ( 2–16 years old ) with tonsillopharyngitis were enrolled ; 537 were evaluable for efficacy . Follow-up evaluations were performed at 4–8 and 21–28 days after therapy . Results : At enrollment , 26 % of the Streptococcus pyogenes isolates were clarithromycin-nonsusceptible . All regimens had an apparently similar clinical efficacy . The long term S. pyogenes eradication rates were 102 of 123 ( 83 % ) with amoxicillin/clavulanate and 88 of 114 ( 77 % ) with penicillin V. In the 30- and 1 Output:	High quality evidence showed that Clarithromycin is a safe and effective alternative for the treatment of URIs in pediatric patients . Is superior to other antibiotics in relation to bacterial eradication .
MS2662	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objectives We tested a dental health program in remote Aboriginal communities of Australia 's Northern Territory , hypothesizing that it would reduce dental caries in preschool children . Methods In this 2-year , prospect i ve , cluster-r and omized , concurrent controlled , open trial of the dental health program compared to no such program , 30 communities were allocated at r and om to intervention and control groups . All residents aged 18–47 months were invited to participate . Twice per year for 2 years in the 15 intervention communities , fluoride varnish was applied to children 's teeth , water consumption and daily tooth cleaning with toothpaste were advocated , dental health was promoted in community setting s , and primary health care workers were trained in preventive dental care . Data from dental examinations at baseline and after 2 years were used to compute net dental caries increment per child ( d3mfs ) . A multi-level statistical model compared d3mfs between intervention and control groups with adjustment for the clustered r and omization design ; four other models used additional variables for adjustment . Results At baseline , 666 children were examined ; 543 of them ( 82 % ) were re-examined 2 years later . The adjusted d3mfs increment was significantly lower in the intervention group compared to the control group by an average of 3.0 surfaces per child ( 95 % CI = 1.2 , 4.9 ) , a prevented fraction of 31 % . Adjustment for additional variables yielded caries reductions ranging from 2.3 to 3.5 surfaces per child and prevented fractions of 24–36 % . Conclusions These results corroborate findings from other studies where fluoride varnish was efficacious in preventing dental caries in young children OBJECTIVE This paper reports the results of a community trial to measure the clinical impact of a linked series of interventions on Early Childhood Caries ( ECC ) and general caries levels among five-year-old children . It exemplifies the problems of undertaking population based interventions in deprived communities . RESEARCH DESIGN Two health districts ( Primary Care Groups ) were matched for dental disease levels and socio-demographic factors . One was r and omly allocated to be the active intervention PCG , the other the comparison PCG . Children in the active PCG received a series of interventions to support positive dental health behaviour from the age of 8 to 32 months . Clinical examinations were undertaken on a cohort of 5-year-old children in both active and comparison PCGs . SETTING In the active PCG , children who attended design ated clinics for their 8-month developmental checks and /or MMR inoculations at 12 to 15 months , were given gift bags , the first contained a trainer cup , the second fluoride toothpaste ( 1450 ppm F ) and toothbrush . Parents were also given written , pictorial and verbal advice on oral care . Further supplies of toothpaste and brushes were posted to the children 's homes at 20 , 26 and 32 months . When five years of age children in the two PCGs were examined in school . OUTCOME MEASURES Severity and prevalence of ECC and general caries . Levels of participation . RESULTS Among participants in the active PCG the prevalence of ECC , general caries and extraction experience and mean dmft ( 20 % : 54 % : 3 % : 2.2 ) were lower than in ' participants ' in the comparison area ( 32 % : 64 % : 12 % : 3.7 ) . All differences were statistically significant . When all children ( participants and non- participants ) in the two PCGs were compared , the differences were much reduced ( 30 % : 63 % : 6 % : 3.1 vs. 32 % : 64 % : 12 % : 3.6 ) . A higher proportion of children in the active PCG area ( 47 % ) were found not to have participated in the interventions , when compared to 21 % in the comparison area . Disease levels in the non- participants in the active PCG were particularly high . The impact of participation bias , changes in baseline balance , population mobility and alternative study design on outcomes are explored . CONCLUSION The impact of non-participation in a deprived , urban conurbation with high levels of population mobility are sufficient to dilute the impact of a health intervention such that few benefits are discernible at a population level OBJECTIVE To assess the impact of regularly supplying free fluoride toothpaste regularly to children , initially aged 12 months , and living in deprived areas of the north west of Engl and on the level of caries in the deciduous dentition at 5 - 6 years of age . A further aim was to compare the effectiveness of a programme using a toothpaste containing 440 ppmF ( Colgate 0 - 6 Gel ) with one containing 1,450 ppmF ( Colgate Great Regular Flavour ) in reducing caries . DESIGN R and omised controlled parallel group clinical trial . Clinical data were collected from test and control groups when the children were 5 - 6 years old . SETTING A programme of posting toothpaste with dental health messages to the homes of children initially aged 12 months . Clinical examinations took place in primary schools . PARTICIPANTS 7,422 children born in 3-month birth cohorts living in high caries areas in nine health districts in north west Engl and . Within each district children were r and omly assigned to test or control groups . INTERVENTIONS Toothpaste , containing either 440 ppmF or 1450 ppmF , and dental health literature posted at three monthly intervals to children in test groups until they were aged 5 - 6 years . MAIN OUTCOME MEASURES The dmft index , missing teeth and the prevalence of caries experience . RESULTS An analysis of 3,731 children who were examined and remained in the programme showed the mean dmft to be 2.15 for the group who had received 1,450 ppmF toothpaste and 2.49 for the 440 ppmF group . The mean dmft for the control group was 2.57 . This 16 % reduction between the 1,450 ppmF and control group was statistically significant ( P<0.05 ) . The difference between the 440 ppmF group and control was not significant . Further analyses to estimate the population effect of the programme also confirmed this relationship . CONCLUSION This study demonstrates that a programme distributing free toothpaste containing 1,450 ppmF provides a significant clinical benefit for high caries risk children living in deprived , non-fluori date d districts OBJECTIVE The medical centre at Almirante Nef Naval Hospital , Vina del Mar , Chile , operates a mother and child preventive dental program ( PDP ) which includes women from their fourth month of pregnancy and mothers with their offspring . The aim was to evaluate the effectiveness of this prenatal and postnatal prevention program after the first four years . METHODS The prevalence of early childhood caries of 180 1- to 3.5-year-old children enrolled in the PDP was compared with 180 non-participating children . The control group was r and omly selected from the rolls of the healthy child system of of the Valparaiso-San Antonio Health Service and was comparable by age , socio-economic status and level of fluoride in the drinking water ( 1.0 p.p.m . F ) with the PDP group . Clinical caries examinations were conducted by two calibrated examiners using the WHO visual criteria . RESULTS In the PDP group , 97 % of the children were caries free compared with the 77 % in the control group . The dft ( mean + /- SD ) of the PDP children was 0.11 + /- 0.78 versus 0.66 + /- 1.55 for the control children , a difference of 83.3 % . The differences between the groups in caries-free status and caries prevalence were both statistically significant ( P < 0.05 ) . CONCLUSIONS The preventive dental program was effective in inhibiting caries in pre-school children , even in a population already receiving the benefits of community water fluoridation Background Motivational Interviewing ( MI ) has been used across primary healthcare and been shown to be effective in reducing the prevalence of early childhood caries ( ECC ) in preschool children . This study aim ed to compare the effect of MI , in contrast to traditional dental health education ( DHE ) , on oral health knowledge , attitudes , beliefs and behaviours among parents and caregivers of preschool children in Trinidad . Method The design of this exploratory study included a cluster r and omised controlled trial and semi-structured focus groups . Six preschools ( 79 parents and caregivers ) in Eastern Trinidad were r and omly assigned to a test or control group ( 3 preschools in each group ) . Parents and caregivers in the test-group ( n = 25 ) received a talk on dental health using an MI approach and the control-group ( n = 54 ) received a talk using traditional DHE . Both groups received additional , written dental health information . The MI group also received two telephone call follow-ups as part of the MI protocol . Both groups were given question naires before the talks and four months later . Question items included oral health knowledge , beliefs , attitudes , brushing behaviour , oral health self-efficacy , oral health fatalism and a specific instrument to asses ‘ readiness for change ’ , the Readiness Assessment of Parents Concerning Infant Dental Decay ( RAPIDD ) . Participants in the test-group were also invited to take part in a focus group to share their views on the dental health talk . Results At four month follow-up , knowledge items on fluoride use , tooth brushing , dietary practice and dental attendance increased in both the test ( DHE + MI ) and control ( DHE ) groups ( ( p < 0.05 , Chi Square test ) . In the test-group there were increases in mean child tooth brushing frequency and reduction in oral health fatalism ( p < 0.05 t-test ) . Findings from a thematic analysis of the focus group suggested that the MI talk and telephone follow-up were well accepted and helpful in supporting parent and caregiver efforts to improve oral health practice s for their preschool children . Conclusion In this exploratory controlled study there was some evidence that using an MI approach when delivering oral health information had a positive effect on parent/ caregiver oral health knowledge , attitudes and behaviours compared to traditional DHE . There is need for further research involving the use of brief-counselling techniques in this Caribbean population Abstract Objective . ( 1 ) To evaluate the dental status of 5-year-old children in Clermont-Ferr and ( France ) in 2009 ; ( 2 ) To measure changes in children 's dental status between 2003 and 2009 ; and ( 3 ) To estimate the impact of an Oral Health Promotion ( OHP ) program implemented in nine schools since 2005 . Material s and methods . All 5-year-olds attending public schools in deprived areas ( n = 15 ) and six r and omly selected other schools in Clermont-Ferr and were invited to participate . Dental status was recorded using d3mft , as in 2003 . Parents responded to questions about their child 's oral hygiene and provided socio-demographic information . Results . Of children invited , 478 ( 77 % ) were examined . Mean dmft was 1.18 ( SD 2.61 ) ; 27.6 % had at least one tooth affected . Caries experience varied significantly with deprivation status , oral hygiene and household SES indicators . The only difference observed between 2003 and 2009 was an increase in the ‘ f ’ component ( p < 0.001 ) . Dental status had slightly deteriorated in areas characterized in 2003 by low caries levels ( p=0.07 ) . In deprived areas , mean dmft increased in schools without the OHP program ( p = 0.04 ) . Changes between 2003 and 2009 were studied at school level using Multiple Factorial Analysis ; it tended to improve in four schools , which had the OHP program . Household indicators of SES changed little . Oral hygiene levels varied differently from one school to another . Conclusions . Caries experience was high , with large inequalities between children . No major differences were observed between 2003 and 2009 . The OHP program has done little to reduce disparities in oral health , even if dental status improved in four schools PURPOSE The aim of this study was to assess the caries prevalence in the adult population of Pomerania , Germany in comparison to national and international data . MATERIAL S AND METHODS The study sample comprised 4,022 r and omly selected subjects who were examined from October 1997 to May 2001 within the " Study of Health in Pomerania " ( medical and dental , population -based cross-sectional study in Pomerania , Northeast Germany . Response rate : 69 % . Age range of subjects : 25 - 79 yrs ) . Carious defects , fillings and missing teeth were diagnosed and the DMFT/S scores were calculated according to WHO guidelines ( 1997 ) . These figures were compared to other German , Swedish and US data . RESULTS Women exhibited higher mean DMFT and DMFS values in all age groups than men . The mean DMFT/S scores were slightly higher than the values for the only two available nationally representative age groups in Germany . The prevalence of primary carious lesions or secondary caries was very low , result ing in minor treatment needs ( decayed surfaces : mean 0.95 + /- 3.3 ) and high care indices ( FS/DFS ) for all age groups ( 90 - 95 % ) . In contrast to this , the mean numbers of fillings in adults and especially of missing teeth in seniors were much higher in Pomerania for all age groups than in the Swedish and US adult population , where a caries decline was demonstrated . CONCLUSION In spite of a very low Output:	High evidence of mostly high magnitude was retrieved for behavioural interventions in early childhood caries ( ECC ) , weak evidence for a small effect in proximal caries and an unclear effect of specific informational/motivational programmes on prevention of periodontal diseases and no evidence of root caries . CONCLUSION Early childhood caries can be successfully prevented by population -based preventive programmes via aim ing at the change in behaviour . The effect of individual specific motivational/informational interventions has not yet been clearly demonstrated neither for the prevention of caries nor for periodontal diseases
MS2663	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Percutaneous treatment of patients with ST segment elevation myocardial infa rct ion ( STEMI ) has become the st and ard and default mode of management as recommended by the European Society of Cardiology guidelines for managing acute myocardial infa rct ion in patients presenting with STEMI . The choice of vascular access is made by the operator and has a potential impact on the safety and efficacy of the procedure and outcomes . AIM To underst and the influence of a radial approach on bleeding complications and angiographic success , we performed a prospect i ve , controlled r and omised trial . METHODS Patients were allocated to radial ( TR ) or femoral ( TF ) vascular access . The primary endpoints were major bleeding by the REPLACE-2 scale and minor bleeding by the EASY scale ( TR arm ) or the FEMORAL scale ( TF arm ) . Other outcomes included procedural data , in-hospital and long-term survival . RESULTS There were 103 patients analysed in total , 52 in the TR arm and 51 in the TF arm . The demographic and clinical baseline characteristics were well matched between the two study groups . The frequency of the primary endpoint was the same in both arms ( TR : 25.0 % vs. TF : 33.3 % , p = 0.238 ) . In per protocol analysis , there was a significant benefit of the TR approach among independent operators ( 17.4 % vs. 36.8 % , p = 0.038 ) . Major bleeding by the REPLACE-2 scale occurred in 4.2 % of patients ( TR : 5.8 % vs. TF : 3.9 % , p = 0.509 ) . There were no differences in terms of the rate of major cardiac adverse events , which happened in 10.7 % of the study population ( TR : 9.6 % vs. TF : 11.8 % , p = 0.48 ) . In the TF arm , there was a trend towards a higher risk of local bleedings ( TR : 22.4 % vs. TF : 37.7 % , p = 0.081 ) and a significantly higher frequency of local haematoma ( class III , EASY/FEMORAL ) ( TR : 0 % vs. TF : 9.8 % , p = 0.027 ) . CONCLUSIONS There were no significant differences between the TR and TF approaches in terms of clinical efficacy and patient safety . However , patients treated by independent operators might benefit from TR access . The overall complication risk of percutaneous coronary intervention treatment of STEMI patients remains low OBJECTIVES The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access . BACKGROUND In patients with acute coronary syndrome , bleeding is a significant predictor of worse outcome . Access site complications represent a significant source of bleeding for those patients undergoing revascularization , especially when femoral access is used . METHODS The RIFLE-STEACS ( Radial Versus Femoral R and omized Investigation in ST-Elevation Acute Coronary Syndrome ) was a multicenter , r and omized , parallel-group study . Between January 2009 and July 2011 , 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary /rescue percutaneous coronary intervention were r and omized to the radial ( 500 ) or femoral ( 501 ) approach at 4 high-volume centers . The primary endpoint was the 30-day rate of net adverse clinical events ( NACEs ) , defined as a composite of cardiac death , stroke , myocardial infa rct ion , target lesion revascularization , and bleeding ) . Individual components of NACEs and length of hospital stay were secondary endpoints . RESULTS The primary endpoint of 30-day NACEs occurred in 68 patients ( 13.6 % ) in the radial arm and 105 patients ( 21.0 % ) in the femoral arm ( p = 0.003 ) . In particular , compared with femoral , radial access was associated with significantly lower rates of cardiac mortality ( 5.2 % vs. 9.2 % , p = 0.020 ) , bleeding ( 7.8 % vs. 12.2 % , p = 0.026 ) , and shorter hospital stay ( 5 days first to third quartile range , 4 to 7 days ] vs. 6 [ range , 5 to 8 days ] ; p = 0.03 ) . CONCLUSIONS Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits , in terms of both lower morbidity and cardiac mortality . Thus , it should become the recommended approach in these patients , provided adequate operator and center expertise is present . ( Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [ RIFLE-STEACS ] ; NCT01420614 ) Although transradial angioplasty has been shown to have no major entry site – related complications , its clinical applicability for balloon angioplasty and stenting in acute myocardial infa rct ion ( AMI ) is unclear . In order to assess the feasibility , safety , and clinical outcome of transradial access for coronary angioplasty ( PTCA ) and stenting during AMI , transradial angioplasty for AMI was registered on a prospect i ve data base at two European sites ( A and B ) with experience in the radial approach ( RA ) ; 6 Fr catheters with an inner lumen of at least 0.064″ and low‐profile rapid‐exchange balloons were used . Primary success rates and procedural complications of 6 Fr RA were determined and compared to 6 Fr femoral approach ( FA ) procedures . A total of 1,224 AMI patients entered the registry . Study site A enrolled 185 RA patients ( 13.6 % AMI ) and study site B 92 RA patients ( 63.4 % ) . Patient baseline demographics were similar in both study centers and showed no differences between RA and FA patients , except a more frequent use of abciximab in study site B compared to A. PTCA was successful in > 95 % of both RA and FA patients . Total procedural time did not differ between RA and FA patients . Severe access site – related bleeding complications , however , were observed in FA patients only : study site A used closure devices routinely and found 2 % severe bleedings ; study site B used no closure device for FA patients and observed 7 % severe bleedings . In selected patients and in experienced h and s , transradial PTCA in AMI has a high success rate , is clinical ly safe , and could become an attractive alternative access site for patients being at high or even low risk for bleeding complications . Cathet Cardiovasc Intervent 2002;55:206–211 . © 2002 Wiley‐Liss , Transradial coronary intervention ( TRI ) can be performed in elective patients with low incidence of access site complications . However , the feasibility of primary stent implantation by TRI is still not clear in patients with acute myocardial infa rct ion ( AMI ) . We prospect ively r and omized 149 patients out of 213 patients with AMI within 12 hr from onset into two groups : 77 patients treated by TRI ( TRI group ) and 72 patients by transfemoral coronary intervention ( TFI ; TFI group ) . We compared the incidences of major adverse cardiac events ( MACE ; repeat MI , target lesion revascularization , and cardiac death ) during the initial hospitalization and 9‐month follow‐up periods in both groups . There were one patient who crossed over to the opposite arm , and two patients with severe bleeding complications in the TFI group . Background characteristics of patients were similar between the two groups . The success rate of reperfusion and the incidence of in‐hospital MACE were similar in both groups ( 96.1 % and 5.2 % vs. 97.1 % and 8.3 % in TRI and TFI groups , respectively ) . In selected patients with AMI , primary stent implantation by TRI is feasible as compared to TFI . Cathet Cardiovasc Intervent 2003;59:26–33 . © 2003 Wiley‐Liss , CONTEXT It is unclear if blood transfusion in anemic patients with acute coronary syndromes is associated with improved survival . OBJECTIVE To determine the association between blood transfusion and mortality among patients with acute coronary syndromes who develop bleeding , anemia , or both during their hospital course . DESIGN , SETTING , AND PATIENTS We analyzed 24,112 enrollees in 3 large international trials of patients with acute coronary syndromes ( the GUSTO IIb , PURSUIT , and PARAGON B trials ) . Patients were grouped according to whether they received a blood transfusion during the hospitalization . The association between transfusion and outcome was assessed using Cox proportional hazards modeling that incorporated transfusion as a time-dependent covariate and the propensity to receive blood , and a l and mark analysis . MAIN OUTCOME MEASURE Thirty-day mortality . RESULTS Of the patients included , 2401 ( 10.0 % ) underwent at least 1 blood transfusion during their hospitalization . Patients who underwent transfusion were older and had more comorbid illness at presentation and also had a significantly higher unadjusted rate of 30-day death ( 8.00 % vs 3.08 % ; P<.001 ) , myocardial infa rct ion ( MI ) ( 25.16 % vs 8.16 % ; P<.001 ) , and death/MI ( 29.24 % vs 10.02 % ; P<.001 ) compared with patients who did not undergo transfusion . Using Cox proportional hazards modeling that incorporated transfusion as a time-dependent covariate , transfusion was associated with an increased hazard for 30-day death ( adjusted hazard ratio [ HR ] , 3.94 ; 95 % confidence interval [ CI ] , 3.26 - 4.75 ) and 30-day death/MI ( HR , 2.92 ; 95 % CI , 2.55 - 3.35 ) . In the l and mark analysis that included procedures and bleeding events , transfusion was associated with a trend toward increased mortality . The predicted probability of 30-day death was higher with transfusion at nadir hematocrit values above 25 % . CONCLUSIONS Blood transfusion in the setting of acute coronary syndromes is associated with higher mortality , and this relationship persists after adjustment for other predictive factors and timing of events . Given the limitations of post hoc analysis of clinical trials data , a r and omized trial of transfusion strategies is warranted to resolve the disparity in results between our study and other observational studies . We suggest caution regarding the routine use of blood transfusion to maintain arbitrary hematocrit levels in stable patients with ischemic heart disease BACKGROUND The transradial approach for percutaneous coronary intervention ( PCI ) seems to be superior to transfemoral . The safety and efficacy of transradial approach for PCI in acute myocardial infa rct ion is not well-established . METHODS Hundred patients with acute myocardial infa rct ion qualified to PCI were r and omly assigned to transradial ( group I ; n = 50 ) and transfemoral ( group II ; n = 50 ) approaches . RESULTS PCI was successful for almost all patients , except one from group II . There were no significant differences between groups in X-ray exposition , volume of contrast and total procedure duration . Small but significant elongation of door to stent time in group I was caused mostly by a longer time between beginning of procedure and arterial sheath introduction . Major bleeding complications occurred in three patients from group I and seven from group II . There were no significant differences observed between the two groups . Time to ambulation in group I was significantly shorter then in group II ( 22.6 + /- 10.3 h vs. 34.7 + /- 34.6 h ; p = 0.003 ) . CONCLUSIONS The transradial approach for PCI in acute myocardial infa rct ion has the same efficacy as transfemoral . There are no differences in total procedure duration , X-ray exposition or volume of contrast between the two approaches . A longer time from the patient 's admission to the individual stages of the PCI procedure in group I was mostly due to the longer times of the initial stages of the procedure . The use of transradial approach reduces the time to ambulation and allows rehabilitation to begin sooner . In both groups , bleeding complications occurred rarely BACKGROUND Transradial percutaneous coronary intervention ( PCI ) results in fewer vascular complications , earlier ambulation , and improved patient comfort . Limited data exist for radial access in acute myocardial infa rct ion , where reperfusion must occur quickly . METHODS In a multicenter pilot trial , 50 patients with myocardial infa rct ion requiring either primary or rescue PCI were r and omized to radial or femoral access . All operators had previously performed at least 100 transradial cases . Procedure times were prospect ively recorded . RESULTS Thrombolysis was used in 66 % of the cases and glycoprotein IIb/IIIa inhibitors in 94 % . Crossover from radial to femoral access was required in one case . Percutaneous coronary intervention was performed in 47 patients , with stenting in 45 . One procedural failure occurred with radial access because of inability to cross the occlusion . The time from local anesthesia to first balloon inflation was 32 ( 25th percentile 26 , 75th percentile 38 ) minutes for radial access and 26 ( 22 , 33 ) minutes for femoral access ( P = .04 ) . There were Output:	Based on this large meta- analysis , RA for primary PCI in the setting of ACS is associated with reduction in cardiac and safety endpoints when compared with FA in both urgent and elective procedures .
MS2664	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To test whether early postnatal ( 0 to 3 hours ) intravenous administration of ibuprofen will prevent patent ductus arteriosus ( PDA ) in preterm neonates . DESIGN Prospect i ve sequential controlled trial with three treatment arms . SETTING Level 3 perinatal-neonatal intensive care nursery . PATIENTS Thirty-four premature newborn infants born from February to August 1993 with a mean birth weight of 913 g ( range , 565 to 1460 g ) and gestational age of 26.9 weeks ( range , 22.4 to 31.0 ) . INTERVENTION Infants were consecutively assigned within 3 hours of age to treatment with either one dose of ibuprofen lysine ( 10 mg/kg intravenously ) followed by 5 mg/kg per dose intravenously at 24 and 48 hours of age ( n = 12 ) , one dose of ibuprofen lysine ( 10 mg/kg intravenously ; n = 11 ) , or saline ( n = 11 ) . OUTCOME VARIABLES Primary outcome variable was the presence of ductus arteriosus by echocardiography and clinical assessment s at 3 , 7 , and 21 days of life . Secondary outcome variables included presence of intraventricular hemorrhage , renal function , ventilatory and oxygen needs , hematologic changes , gastrointestinal function , time to full enteral feeding , duration of hospitalization , and age at discharge . RESULTS The three groups of patients were comparable in birth weight , gestational age , antenatal administration of betamethasone , and other perinatal characteristics . Ibuprofen treatment significantly reduced plasma levels of prostagl and ins , and the levels remained low for 72 hours in newborns who received three doses of the drug . The incidence of PDA and other variables did not differ between patients who received a single dose of ibuprofen and those given saline . However , compared with the saline-treated newborns , babies who received three doses of ibuprofen had no PDA ( 0/12 vs 7/11 for saline ; P < .02 ) , had lower daily mean airway pressures ( mean + /- SD , 5.2 + /- 1.1 cm H2O vs 8.3 + /- 2.8 cm H2O for saline ; P < .02 ) and better oxygenation index ( 2.6 + /- 0.6 vs 4.7 + /- 1.8 for saline ; P < .02 ) at the end of the first week of life , and required fewer days of ventilation ( 25 + /- 14 days vs 44 + /- 26 days for saline ; P < .03 ) . Babies given three doses of ibuprofen tended to tolerate full oral feedings earlier ( 35 + /- 19 days vs 56 + /- 34 days for saline ; P = .09 ) , had shorter duration of hospitalization ( 71.2 + /- 22.6 days vs 127.3 + /- 74.7 days for saline ; P < .05 ) , and were discharged to home at an earlier postconceptional age ( 37.8 + /- 2.0 weeks vs 44.8 + /- 9.8 weeks for saline ; P < .05 ) . ibuprofen treatment in this phase I trial was not associated with any apparent early neurological , intestinal , renal , hepatic , or hematologic complications . CONCLUSIONS Administration of three doses of ibuprofen within 3 hours after birth in preterm neonates reduced the incidence of PDA without causing notable early adverse drug reactions in this phase I trial . Early closure of the ductus arteriosus was also associated with better respiratory outcome and earlier discharge from the hospital BACKGROUND Indomethacin is the conventional treatment for hemodynamically important patent ductus arteriosus in preterm infants . However , its use is associated with various side effects . In a prospect i ve study , we compared ibuprofen and indomethacin with regard to efficacy and safety for the early treatment of patent ductus arteriosus in preterm infants . METHODS We studied 148 infants ( gestational age , 24 to 32 weeks ) who had the respiratory distress syndrome and an echocardiographically confirmed , hemodynamically important patent ductus arteriosus . The infants were r and omly assigned at five neonatal intensive care centers to receive three intravenous doses of either indomethacin ( 0.2 mg per kilogram of body weight , given at 12-hour intervals ) or ibuprofen ( a first dose of 10 mg per kilogram , followed at 24-hour intervals by two doses of 5 mq per kilogram each ) , starting on the third day of life . The rate of ductal closure , the need for additional treatment , side effects , complications , and the infants ' clinical course were recorded . RESULTS The rate of ductal closure was similar with the two treatments : ductal closure occurred in 49 of 74 infants given indomethacin ( 66 percent ) , and in 52 of 74 given ibuprofen ( 70 percent ) ( relative risk , 0.94 ; 95 percent confidence interval , 0.76 to 1.17 ; P=0.41 ) . The numbers of infants who needed a second pharmacologic treatment or surgical ductal ligation did not differ significantly between the two groups . Oliguria occurred in 5 infants treated with ibuprofen and in 14 treated with indomethacin ( P=0.03 ) . There were no significant differences with respect to other side effects or complications . CONCLUSIONS Ibuprofen therapy on the third day of life is as efficacious as indomethacin for the treatment of patent ductus arteriosus in preterm infants with the respiratory distress syndrome and is significantly less likely to induce oliguria BACKGROUND Patent ductus arteriosus is a common complication of prematurity that frequently requires surgical or medical treatment . The benefit of prophylactic treatment by indometacin , a cyclo-oxygenase inhibitor , remains uncertain compared with curative treatment . This benefit could be improved with ibuprofen , another cyclo-oxygenase inhibitor with fewer adverse effects than indometacin on renal , mesenteric , and cerebral perfusion . We aim ed to compare prophylactic and curative ibuprofen in the treatment of this abnormality in very premature infants . METHODS We did a r and omised controlled trial in infants younger than 28 weeks of gestation , who were r and omly assigned to receive either three doses of ibuprofen or placebo within 6 h of birth . After day 3 , symptomatic patent ductus arteriosus was treated first by open curative ibuprofen , then back-up indometacin , surgery , or both . The primary endpoint was need for surgical ligation . Analysis was per protocol . FINDINGS The study was stopped prematurely after 135 enrollments because of three cases of severe pulmonary hypertension in the prophylactic group . 65 infants received prophylactic ibuprofen , and 66 received placebo . Prophylaxis reduced the need for surgical ligation from six ( 9 % ) to zero ( p=0.03 ) , and decreased the rate of severe intraventricular haemorrhage from 15 ( 23 % ) to seven ( 11 % ) ( p=0.10 ) . However , survival was not improved ( 47 [ 71 % ] placebo vs 47 [ 72 % ] treatment , p=1.00 ) , because of high frequency of adverse respiratory , renal , and digestive events . INTERPRETATION In premature infants , prophylactic ibuprofen reduces the need for surgical ligation of patent ductus arteriosus , but does not reduce mortality or morbidity . Therefore , it should not be preferred to early curative ibuprofen A prospect i ve r and omized controlled trial was performed to compare the effects of ibuprofen with indomethacin on cerebral hemodynamics measured using near infrared spectroscopy in preterm infants during treatment for patent ductus arteriosus . Infants were r and omly assigned to three intravenous doses of either indomethacin ( 0.20–0.25 mg/kg , 12 hourly ) or ibuprofen ( 5–10 mg/kg , 24 hourly ) and also received a dose of saline . The primary end points of the study were the effects of the first dose on cerebral blood flow ( CBF ) and cerebral blood volume . Fifteen infants received indomethacin and 18 received ibuprofen . The group mean ( SD ) values for CBF ( mL·100 g−1·min−1 ) before and after the first dose of indomethacin were 13.6 ( 4.1 ) and 8.3 ( 3.1 ) , respectively , the change being significant ( p < 0.001 ) . In contrast , no significant changes in CBF were observed with the first dose of ibuprofen , the respective before and after values being 13.3 ( 3.2 ) and 14.9 ( 4.7 ) mL·100 g−1·min−1 . The median ( interquartile range ) value for change in cerebral blood volume ( mL/100 g ) after the first dose in the indomethacin group was −0.4 ( −0.3 to −0.6 ) and in the ibuprofen group was 0.0 ( 0.1 to −0.1 ) , the difference between the two groups being significant ( p < 0.001 ) . Cerebral oxygen delivery changed significantly after the first dose in the indomethacin group but not in the ibuprofen group . Significant reductions in CBF , cerebral blood volume , and cerebral oxygen delivery also occurred after the 24-h dose of indomethacin , but there were no significant changes after the 48-h dose of saline in the indomethacin group or after the 24- and 48-h doses of ibuprofen . The patent ductus arteriosus closure rates after indomethacin and ibuprofen were 93 and 78 % , respectively . We conclude that ibuprofen , unlike indomethacin , has no adverse effects on cerebral hemodynamics and appears to mediate patent ductus arteriosus closure We investigated the effects of clinical ly comparable doses of ibuprofen and indomethacin on renal , gastrointestinal and cerebral perfusion in newborn piglets , and hypothesized that ibuprofen would have less effect on regional circulation . Animals were r and omly assigned to receive ibuprofen ( 20 mg/kg , n = 8) , indomethacin ( 0.3 mg/kg , n = 7 ) or vehicle ( n = 6 ) . Fluorescent microspheres were injected prior to and at 20 , 40 , 60 , 90 and 120 min after drug administration . Regional blood flow was measured and vascular resistances were calculated . Cardiovascular and respiratory variables were not significantly affected by either study drug or vehicle . Ibuprofen increased renal cortical and medullary resistance by 44 and 52 % ( p < 0.05 ) . However , ibuprofen had no significant effects on gastrointestinal or cerebral resistance . Indomethacin raised renal cortical and medullary resistance by 66 and 71 % at 60 min postinjection , respectively ( p < 0.05 ) . Indomethacin increased duodenojejunal , ileal and colon resistance by 97 , 102 and 75 % at 60 min , respectively ( p < 0.05 ) . Indomethacin increased cerebral cortical and cerebellar resistance by 92 and 86 % at 90 min ( p < 0.05 ) . While indomethacin and , to a lesser extent , ibuprofen both increase renal vascular resistance , indomethacin vasoconstricts the gastrointestinal and cerebral circulations which are unaffected by ibuprofen Aim The aim of this study was to explore the effects of early oral ibuprofen administration on the incidence of hemodynamically significant patent ductus arteriosus ( hsPDA ) and define the association between serum ibuprofen levels and ductal closure . Method Preterm infants with a gestational age of < 28 weeks and /or birth weight of < 1,000 g were r and omized either to the intervention ( ibuprofen prophylaxis ) or control group . The intervention group received oral ibuprofen 10 mg/kg within 12–24 h after birth followed by 5 mg/kg at 24 and 48 h. Serum ibuprofen levels after the treatment were analyzed in the intervention group , and the incidence of hsPDA and complication rates were compared between two groups . Results Nineteen infants who received one course ( three doses ) of prophylactic ibuprofen in the intervention group and 17 infants in the control group who underwent an echocardiographic examination on the fourth day of life were analyzed . hsPDA was observed in five ( 26 % ) infants in the intervention group and ten ( 58 % ) infants in the control group ( p = 0.09 ) . In the intervention group two infants experienced gastrointestinal bleeding two infants had spontaneous intestinal perforation , and two infants developed acute kidney failure . Mean serum ibuprofen level Output:	Ibuprofen negatively affects renal function . Prophylactic use of ibuprofen decreased the incidence of PDA , decreased the need for rescue treatment with cyclo-oxygenase inhibitors and decreased the need for surgical closure .
MS2665	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE This project aim ed to evaluate the impact of a home visiting programme that targeted families where the child , for environmental reasons , was at great risk of poor health and developmental outcomes . METHODOLOGY Women in the immediate postpartum period were recruited to a r and omized double-blind controlled trial on the basis of self-reported vulnerability factors and were r and omly assigned to receive either a structured programme of nurse home visiting , supported by a social worker and paediatrician ( n = 90 ) , or assigned to a comparison group receiving st and ard community child health services ( n = 91 ) . Parenting stress and maternal depression were measured at enrollment and at 6 weeks . Preventive health behaviour , service satisfaction and home environment outcomes were tested at 6 weeks , as were child health outcomes . RESULTS At six weeks , women receiving the home-based programme had significant reductions in postnatal depression screening scores as well as improvements in their experience of the parental role and improvement in the ability to maintain their own identity . Maternal-infant interactions were more likely to be positive , with significantly higher ( better ) scores in aspects of the home environment related to optimal development in children , particularly maternal-infant secure attachment . Intervention group mothers were significantly more satisfied with the community child health service . CONCLUSIONS This form of intervention for families is effective in promoting secure maternal-infant attachment , preventing maternal mood disorder and is welcomed by the families receiving it . These findings may predict long-term benefits for the healthy development of children otherwise at risk of a range of poor health and development outcomes OBJECTIVE : To estimate the efficacy of a psycho-behavioral intervention in reducing intimate partner violence recurrence during pregnancy and postpartum and in improving birth outcomes in African-American women . METHODS : We conducted a r and omized controlled trial for which 1,044 women were recruited . Women were r and omly assigned to receive either intervention ( n=521 ) or usual care ( n=523 ) . Individually tailored counseling sessions were adapted from evidence -based interventions for intimate partner violence and other risks . Logistic regression was used to model intimate partner violence victimization recurrence and to predict minor , severe , physical , and sexual intimate partner violence . RESULTS : Women r and omly assigned to the intervention group were less likely to have recurrent episodes of intimate partner violence victimization ( odds ratio [ OR ] 0.48 , 95 % confidence interval [ CI ] 0.29–0.80 ) . Women with minor intimate partner violence were significantly less likely to experience further episodes during pregnancy ( OR 0.48 , 95 % CI 0.26–0.86 , OR 0.53 , 95 % CI 0.28–0.99 ) and postpartum ( OR 0.56 , 95 % CI 0.34–0.93 ) . Numbers needed to treat were 17 , 12 , and 22 , respectively , as compared with the usual care group . Women with severe intimate partner violence showed significantly reduced episodes postpartum ( OR 0.39 , 95 % CI 0.18–0.82 ) ; the number needed to treat was 27 . Women who experienced physical intimate partner violence showed significant reduction at the first follow-up ( OR 0.49 , 95 % CI 0.27–0.91 ) and postpartum ( OR 0.47 , 95 % CI 0.27–0.82 ) ; the numbers needed to treat were 18 and 20 , respectively . Women in the intervention group had significantly fewer very preterm neonates ( 1.5 % intervention group , 6.6 % usual care group ; P=.03 ) and an increased mean gestational age ( 38.2±3.3 intervention group , 36.9±5.9 usual care group ; P=.016 ) . CONCLUSION : A relatively brief intervention during pregnancy had discernible effects on intimate partner violence and pregnancy outcomes . Screening for intimate partner violence as well as other psychosocial and behavioral risks and incorporating similar interventions in prenatal care is strongly recommended . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00381823 . LEVEL OF EVIDENCE : OBJECTIVES : Intimate partner violence ( IPV ) during pregnancy affects 0.9 % to 17 % of women and affects maternal health significantly . The impact of IPV extends to the health of children , including an increased risk of complications during pregnancy and the neonatal period , mental health problems , and cognitive delays . Despite substantial sequelae , there is limited research substantiating best practice s for engaging and retaining high-risk families in perinatal home visiting ( HV ) programs , which have been shown to improve infant development and reduce maltreatment . METHODS : The Domestic Violence Enhanced Home Visitation Program ( DOVE ) is a multistate longitudinal study testing the effectiveness of a structured IPV intervention integrated into health department perinatal HV programs . The DOVE intervention , based on an empowerment model , combined 2 evidence -based interventions : a 10-minute brochure-based IPV intervention and nurse home visitation . RESULTS : Across all sites , 689 referrals were received from participating health departments . A total of 339 abused pregnant women were eligible for r and omization ; 42 women refused , and 239 women were r and omly assigned ( 124 DOVE ; 115 usual care ) , result ing in a 71 % recruitment rate . Retention rates from baseline included 93 % at delivery , 80 % at 3 months , 76 % at 6 months , and 72 % at 12 months . CONCLUSIONS : Challenges for HV programs include identifying and retaining abused pregnant women in their programs . DOVE strategies for engaging and retaining abused pregnant women should be integrated into HV programs ’ federal government m and ates for the appropriate identification and intervention of women and children exposed to IPV Background Intimate partner violence ( IPV ) can result in significant harm to women and families and is especially prevalent when women are pregnant or recent mothers . Maternal and child health nurses ( MCHN ) in Victoria , Australia are community-based nurse/midwives who see over 95 % of all mothers with newborns . MCHN are in an ideal position to identify and support women experiencing IPV , or refer them to specialist family violence services . Evidence for IPV screening in primary health care is inconclusive to date . The Victorian government recently required nurses to screen all mothers when babies are four weeks old , offering an opportunity to examine the effectiveness of MCHN IPV screening practice s. This protocol describes the development and design of MOVE , a study to examine IPV screening effectiveness and the sustainability of screening practice . Methods / design MOVE is a cluster r and omised trial of a good practice model of MCHN IPV screening involving eight maternal and child health nurse teams in Melbourne , Victoria . Normalisation Process Theory ( NPT ) was incorporated into the design , implementation and evaluation of the MOVE trial to enhance and evaluate sustainability . Using NPT , the development stage combined participatory action research with intervention nurse teams and a systematic review of nurse IPV studies to develop an intervention model incorporating consensus guidelines , clinical pathway and strategies for individual nurses , their teams and family violence services . Following twelve months ’ implementation , primary outcomes assessed include IPV inquiry , IPV disclosure by women and referral using data from MCHN routine data collection and a survey to all women giving birth in the previous eight months . IPV will be measured using the Composite Abuse Scale . Process and impact evaluation data ( online surveys and key stakeholders interviews ) will highlight NPT concepts to enhance sustainability of IPV identification and referral . Data will be collected again in two years . Discussion MOVE will be the first r and omised trial to determine IPV screening effectiveness in a community based nurse setting and the first to examine sustainability of an IPV screening intervention . It will further inform the debate about the effectiveness of IPV screening and describe IPV prevalence in a community based post-partum and early infant population .Trial registration BACKGROUND Intimate partner violence ( IPV ) during pregnancy poses a significant health risk to the mother and developing fetus . Practice guidelines recommend that prenatal providers screen for and counsel their patients about IPV , yet many physicians express reluctance or discomfort regarding such discussion s. The Health in Pregnancy ( HIP ) computer program was design ed to improve prenatal providers ' counseling about behavioral risks . METHODS English-speaking women 18 years or older , less than 26-weeks pregnant , and receiving prenatal care at one of the five participating clinics in the San Francisco area , were r and omized in parallel groups in a controlled trial ( June 2006-present ; data analyzed June 2007 ) . Participants reporting one or more risks were r and omized to intervention or control in stratified blocks . Providers received summary " cueing sheets " alerting them to their patient 's risk(s ) and suggesting counseling statements . RESULTS Thirteen percent ( 37/286 ) of the sample reported current IPV . Provider cueing result ed in 85 % of the IPV-intervention group reporting discussion s with their provider , compared to 23.5 % of the control group ( p<0.001 ) . CONCLUSIONS IPV discussion s were influenced strongly by cueing providers . Provider cueing is an effective and appropriate adjunct to routine risk counseling in prenatal care This study examines whether an integrated behavioral intervention with proven efficacy in reducing psycho-behavioral risks ( smoking , environmental tobacco smoke exposure ( ETSE ) , depression , and intimate partner violence ( IPV ) ) in African-Americans is associated with improved pregnancy outcomes . A r and omized controlled trial targeting risks during pregnancy was conducted in the District of Columbia . African-American women were recruited if reporting at least one of the risks mentioned above . R and omization to intervention or usual care was site and risk specific . Sociodemographic , health risk and pregnancy outcome data were collected . Data on 819 women , and their singleton live born infants were analyzed using an intent-to-treat approach . Bivariate analyses preceded a reduced logistical model approach to eluci date the effect of the intervention on the reduction of prematurity and low birth weight . The incidence of low birthweight ( LBW ) was 12 % and very low birthweight ( VLBW ) was 1.6 % . Multivariate logistic regression results showed that depression was associated with LBW ( OR = 1.71 , 95 % CI = 1.12–2.62 ) . IPV was associated with preterm birth ( PTB ) and very preterm birth ( VPTB ) ( OR 1.64 , 95 % CI = 1.07–2.51 , OR = 2.94 , 95 % CI = 1.40–6.16 , respectively ) . The occurrence of VPTB was significantly reduced in the intervention compared to the usual care group ( OR = 0.42 , 95 % CI = 0.19 - 0.93 ) . Our study confirms the significant associations between multiple psycho-behavioral risks and poor pregnancy outcomes , including LBW and PTB . Our behavioral intervention with demonstrated efficacy in addressing multiple risk factors simultaneously reduced VPTB within an urban minority population OBJECTIVES To estimate whether home visitation beginning after childbirth was associated with changes in average rates of mothers ' intimate partner violence ( IPV ) victimization and perpetration as well as rates of specific IPV types ( physical assault , verbal abuse , sexual assault , and injury ) during the 3 years of program implementation and during 3 years of long-term follow-up . DESIGN R and omized controlled trial . SETTING Oahu , Hawaii . PARTICIPANTS Six hundred forty-three families with an infant at high risk for child maltreatment born between November 1994 and December 1995 . Intervention Home visitors provided direct services and linked families to community re sources . Home visits were to initially occur weekly and to continue for at least 3 years . MAIN OUTCOME MEASURES Women 's self-reports of past-year IPV victimization and perpetration using the Conflict Tactics Scale . Blinded research staff conducted maternal interviews following the child 's birth and annually when children were aged 1 to 3 years and then 7 to 9 years . RESULTS During program implementation , intervention mothers as compared with control mothers reported lower rates of IPV victimization ( incidence rate ratio [ IRR ] , 0.86 ; 95 % confidence interval [ CI ] , 0.73 - 1.01 ) and significantly lower rates of perpetration ( IRR , 0.83 ; 95 % CI , 0.72 - 0.96 ) . Considering specific IPV types , intervention women reported significantly lower rates of physical assault victimization ( IRR , 0.85 ; 95 % CI , 0.71 - 1.00 ) and perpetration ( IRR , 0.82 ; 95 % CI , 0.70 - 0.96 ) . During long-term follow-up , rates of overall IPV victimization and perpetration decreased , with nonsignificant between-group differences . Verbal abuse victimization rates ( IRR , 1.14 , 95 % CI , 0.97 - 1.34 ) may have increased among intervention mothers . CONCLUSION Early-childhood home visitation may be a promising strategy for reducing IPV Background : A pregnant woman 's psychological health is a significant predictor of postpartum outcomes . The Antenatal Psychosocial Health Assessment ( ALPHA ) form incorporates 15 risk factors associated with poor postpartum outcomes of woman abuse , child abuse , postpartum depression and couple dysfunction . We sought to determine whether health care providers using the ALPHA form detected more antenatal psychosocial concerns among Output:	Finally , the risk for low birthweight ( < 2500 g ) did not differ between groups ( RR 0.74 , 95 % CI 0.41 to 1.32 , 306 infants , low quality ) .There were few statistically significant differences between intervention and control groups for depression during pregnancy and the postnatal period . AUTHORS ' CONCLUSIONS There is insufficient evidence to assess the effectiveness of interventions for domestic violence on pregnancy outcomes . There is a need for high- quality , RCTs with adequate statistical power to determine whether intervention programs prevent or reduce domestic violence episodes during pregnancy , or have any effect on maternal and neonatal mortality and morbidity outcomes
MS2666	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Insulin pump therapy ( continuous subcutaneous insulin infusion [ CSII ] ) and multiple daily injections ( MDIs ) with insulin glargine as basal insulin and mealtime insulin lispro have not been prospect ively compared in people naïve to either regimen in a multicenter study . We aim ed to help close that deficiency . RESEARCH DESIGN AND METHODS People with type 1 diabetes on NPH-based insulin therapy were r and omized to CSII or glargine-based MDI ( both otherwise using lispro ) and followed for 24 weeks in an equivalence design . Fifty people were correctly r and omized , and 43 completed the study . RESULTS Total insulin requirement ( mean ± SD ) at end point was 36.2 ± 11.5 units/day on CSII and 42.6 ± 15.5 units/day on MDI . Mean A1C fell similarly in the two groups ( CSII −0.7 ± 0.7 % ; MDI −0.6 ± 0.8 % ) with a baseline-adjusted difference of −0.1 % ( 95 % CI −0.5 to 0.3 ) . Similarly , fasting blood glucose and other prepr and ial , postpr and ial , and nighttime self-monitored plasma glucose levels did not differ between the regimens , nor did measures of plasma glucose variability . On CSII , 1,152 hypoglycemia events were recorded by 23 of 28 participants ( 82 % ) and 1,022 in the MDI group by 27 of 29 patients ( 93 % ) ( all hypoglycemia differences were nonsignificant ) . Treatment satisfaction score increased more with CSII ; however , the change in score was similar for the groups . Costs were ∼3.9 times higher for CSII . CONCLUSIONS In unselected people with type 1 diabetes naïve to CSII or insulin glargine , glycemic control is no better with the more expensive CSII therapy compared with glargine-based MDI therapy OBJECTIVE Multiple daily injection ( MDI ) therapy of bolus insulin aspart and basal insulin glargine was compared with continuous subcutaneous insulin infusion ( CSII ) with aspart in type 1 diabetic patients previously treated with CSII . RESEARCH DESIGN AND METHODS One hundred patients were enrolled in a r and omized , multicenter , open-label , crossover study . After a 1-week run-in period with aspart by CSII , 50 subjects were r and omly assigned to MDI therapy ( aspart immediately before each meal and glargine at bedtime ) and 50 subjects continued CSII . After 5 weeks of the first treatment , subjects crossed over to the alternate treatment for 5 weeks . During the last week of each treatment period , subjects wore a continuous glucose monitoring system for 48 - 72 h. RESULTS Mean serum fructosamine levels were significantly lower after CSII therapy than after MDI therapy ( 343 + /- 47 vs. 355 + /- 50 micromol/l , respectively ; P = 0.0001 ) . Continuous glucose monitoring profiles over a 24-h time period showed that glucose exposure was 24 and 40 % lower for CSII than MDI as measured by area under the curve ( AUC ) glucose > /=80 mg/dl ( 1,270 + /- 742 vs. 1,664 + /- 1,039 mg . h . dl(-1 ) ; P < 0.001 ) and AUC glucose > /=140 mg/dl ( 464 + /- 452 vs. 777 + /- 746 mg . h . dl(-1 ) , CSII vs. MDI , respectively ; P < 0.001 ) . Similar percentages of subjects reported hypoglycemic episodes ( CSII : 92 % , MDI : 94 % ) and nocturnal ( 12:00 a.m. to 8:00 a.m. ) hypoglycemic episodes ( CSII : 73 % , MDI : 72 % ) . Major hypoglycemia was infrequent ( CSII : two episodes , MDI : five episodes ) . CONCLUSIONS In a trial of short duration , CSII therapy with insulin aspart result ed in lower glycemic exposure without increased risk of hypoglycemia , as compared with MDI with insulin aspart and glargine OBJECTIVE Effects of pump treatment vs. four times daily injections were explored in children with diabetes with regard to quality of life and impact of disease as well as adverse effects and parameters of metabolic control . METHODS An open , parallel , r and omized controlled prospect i ve comparative study lasting 14 months was completed by 38 type 1 children with diabetes ( age 4 - 16 yr ) following a 3.5-months run-in phase . St and ardized quality -of-life Pediatric Quality of life Inventory ( PedsQL ) and impact of disease scores were obtained every 3.5 months as well as regular medical parameters . Parallel treatment group data and longitudinal within-patient data were analysed for each treatment modality . RESULTS Within-patient comparisons of the two treatment modalities showed significant improvement in PedsQL and impact scores after pump treatment . Treatment group comparisons did not show significant improvement . Pump treatment result ed in decreased symptomatic hypoglycaemia and lowered haemoglobin A1c by 0.22 % after run in . CONCLUSIONS Within-patient comparison suggests that metabolic control , frequency of severe hypoglycaemia ( a threefold decrease ) , quality of life and impact of disease scores are improved by pump treatment in comparison to regular treatment with four daily insulin injections AIMS The goal of the study was to determine whether continuous subcutaneous insulin infusion ( CSII ) differs from a multiple daily injection ( MDI ) regimen based on neutral protamine hagedorn ( NPH ) as basal insulin with respect to glycaemic control and quality of life in people with Type 1 diabetes . METHODS The 5-Nations trial was a r and omized , controlled , crossover trial conducted in 11 European centres . Two hundred and seventy-two patients were treated with CSII or MDI during a 2-month run-in period followed by a 6-month treatment period , respectively . The quality of glycaemic control was assessed by HbA(1c ) , blood glucose values , and the frequency of hypoglycaemic events . For the evaluation of the quality of life , three different self-report question naires have been assessed . RESULTS CSII treatment result ed in lower HbA(1c ) ( 7.45 vs. 7.67 % , P < 0.001 ) , mean blood glucose level ( 8.6 vs. 9.4 mmol/l , P < 0.001 ) and less fluctuation in blood glucose levels than MDI ( + /- 3.9 vs. + /- 4.3 mmol/l , P < 0.001 ) . There was a marked reduction in the frequency of hypoglycaemic events using CSII compared with MDI , with an incidence ratio of 1.12 [ 95 % confidence interval ( CI ) : 1.08 - 1.17 ] and 2.61 ( 95 % CI : 1.59 - 4.29 ) for mild and severe hypoglycaemia , respectively . The overall score of the diabetes quality of life question naire was higher for CSII ( P < 0.001 ) , and an improvement in pump users ' perception of mental health was detected when using the SF-12 question naire ( P < 0.05 ) . CONCLUSION CSII usage offers significant benefits over NPH-based MDI for individuals with Type 1 diabetes , with improvement in all significant metabolic parameters as well as in patients ' quality of life . Additional studies are needed to compare CSII with glargine- and detemir-based MDI No long-term data are available on the efficacy of glargine insulin in comparison with continuous sc insulin infusion ( CSII ) in children and adolescents affected by Type 1 diabetes ( T1D ) . Our aim was to compare the 2-yr efficacy of the 2 insulin approaches , in order to know how to best supply basal insulin in these patients . Thirty-six 9 to 18-yr-old consecutive children with at least 3 yr previous T1D diagnosis were enrolled . As part of routine clinical care , the patients consecutively changed their previous insulin scheme ( isophane insulin at bedtime and human regular insulin at meals ) and were r and omly selected in order to receive either multiple daily injections ( MDI ) treatment with once-daily glargine and human regular insulin at meals , or CSII with aspart or lispro insulin . Both groups showed a significant decrease in glycosylated hemoglobin ( HbA1c ) values during the 1st year of therapy , though only in the CSII treated children was the decrease also observed during the 2nd year . The overall insulin requirement significantly decreased only in the CSII group and exclusively during the 1st year , while no significant differences were observed concerning body mass index SD score , severe hypoglycémic episodes and basal insulin supplementation . The work illustrates the first long-term study comparing the efficacy of CSII to MDI using glargine as basal insulin in children . Only with CSII were better HbA1c values obtained for prolonged periods of time , so that CSII might be considered the gold st and ard of intensive insulin therapy also for long-term follow-ups OBJECTIVE To assess the impact of continuous glucose monitoring on hypoglycemia in people with type 1 diabetes . RESEARCH DESIGN AND METHODS In this r and omized , controlled , multicenter study , 120 children and adults on intensive therapy for type 1 diabetes and a screening level of glycated hemoglobin A1c ( HbA1c ) < 7.5 % were r and omly assigned to a control group performing conventional home monitoring with a blood glucose meter and wearing a masked continuous glucose monitor every second week for five days or to a group with real-time continuous glucose monitoring . The primary outcome was the time spent in hypoglycemia ( interstitial glucose concentration < 63 mg/dL ) over a period of 26 weeks . Analysis was by intention to treat for all r and omized patients . RESULTS The time per day spent in hypoglycemia was significantly shorter in the continuous monitoring group than in the control group ( mean ± SD 0.48 ± 0.57 and 0.97 ± 1.55 h/day , respectively ; ratio of means 0.49 ; 95 % CI 0.26–0.76 ; P = 0.03 ) . HbA1c at 26 weeks was lower in the continuous monitoring group than in the control group ( difference −0.27 % ; 95 % CI −0.47 to −0.07 ; P = 0.008 ) . Time spent in 70 to 180 mg/dL normoglycemia was significantly longer in the continuous glucose monitoring group compared with the control group ( mean hours per day , 17.6 vs. 16.0 , P = 0.009 ) . CONCLUSIONS Continuous glucose monitoring was associated with reduced time spent in hypoglycemia and a concomitant decrease in HbA1c in children and adults with type 1 diabetes Aims /hypothesisThe value of managing children with type 1 diabetes using a combination of insulin pump and continuous glucose monitoring starting from diagnosis for improving subsequent glycaemic control and preserving residual beta cell function was determined . Methods A total of 160 children ( aged 1–16 years , mean ± SD : 8.7 ± 4.4 years ; 47.5 % girls ) were r and omised to receive insulin pump treatment with continuous glucose monitoring or conventional self-monitoring blood glucose measurements . The primary outcome was the level of HbA1c after 12 months . Other analyses included fasting C-peptide , glycaemic variability , sensor usage , adverse events , children ’s health-related quality of life and parent ’s wellbeing . Results HbA1c was not significantly different between the two groups , but patients with regular sensor use had lower values ( mean 7.1 % , 95 % CI 6.8–7.4 % ) compared with the combined group with no or low sensor usage ( mean 7.6 % , 95 % CI 7.3–7.9 % ; p = 0.032 ) . At 12 months , glycaemic variability was lower in the sensor group ( mean amplitude of glycaemic excursions 80.2 ± 26.2 vs 92.0 ± 33.7 ; p = 0.037 ) . Higher C-peptide concentrations were seen in sensor-treated 12- to 16-year-old patients ( 0.25 ± 0.12 nmol/l ) compared with those treated with insulin pump alone ( 0.19 ± 0.07 nmol/l ; p = 0.033 ) . Severe hypoglycaemia was reported only in the group without sensors ( four episodes ) . Conclusion /interpretationSensor-augmented pump therapy starting from the diagnosis of type 1 diabetes can be associated with less decline in fasting C-peptide particularly in older children , although regular sensor use is a prerequisite for improved glycaemic control . Trial registration IS RCT N.org IS RCT N05450731 Funding Medtronic International Trading Sàrl , Tolochenaz Output:	SUMMARY The AHRQ systematic review of r and omized clinical trials reveals that both insulin delivery modalities ( CSII and MDI ) demonstrate similar effectiveness on glycemic control and severe hypoglycemia in children and adolescents with T1DM and in adults with T2DM . In children and adults with T1DM , the use of CSII was associated with improved quality of life compared with MDI , with low strength of evidence , while there was insufficient strength of evidence to make conclusions regarding the quality of life for adults with T2DM . The study investigators suggest that the modality to deliver intensive insulin therapy can be individualized to patient preference in order to maximize quality of life . On all measured outcomes , there was insufficient or low strength of evidence regarding pregnant women with pre-existing diabetes . The systematic review demonstrates that rt-CGM is associated with greater lowering of A1c compared with SMBG ( high strength of evidence ) without affecting the risk of severe hypoglycemia ( low strength of evidence ) or quality of life ( low strength of evidence ) in nonpregnant individuals with T1DM , particularly when compliance with device use is high . Additional findings suggest that the use of sensor-augmented insulin pumps ( rt-CGM + CSII ) is superior to the use of MDI/SMBG use in lowering A1c in nonpregnant individuals with T1DM ( moderate strength of evidence ) .
MS2667	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: One-hundred twenty-six healthy men with early male pattern baldness completed a 12-month double-blind , controlled trial of 2 % and 3 % topical minoxidil . Subjects were initially r and omly assigned to use placebo or 2 % or 3 % topical minoxidil . After 4 months of study , the placebo group was crossed over to 3 % topical minoxidil . Both objective measurement of hair growth by counting of vellus , terminal , and total hairs in a vertex target balding area and subjective assessment by subject and investigator were done . Treatment of subjects with topical minoxidil for 4 months result ed in a statistically significant increase in terminal hair growth in comparison with placebo therapy . In addition , subjects initially treated with placebo , when crossed over to topical minoxidil , showed a significant increase in the number of terminal hairs . No subject had a net hair loss in the target area during the study . These results indicate that topical minoxidil can increase terminal hair growth in early male pattern baldness A double-blind 12-month trial was conducted to evaluate the safety and efficacy of topical minoxidil in patients with and rogenetic alopecia . During the first 4 months of the study , patients applied a topical solution containing either 2 % minoxidil , 3 % minoxidil , or placebo to their scalps twice daily . At the end of the fourth month , patients taking placebo were crossed over to treatment with 3 % minoxidil solution . Of 60 patients enrolled in the study , 43 were evaluable at month 12 . Hairs were counted in a 1-inch target area and classified as vellus , indeterminate , and terminal ; the latter two classifications were combined as nonvellus hairs for further statistical analysis . All three groups had significant increases in total , nonvellus , and terminal hair counts between baseline and month 4 and between month 4 and month 12 . At month 4 the average total hair counts increased from a baseline mean of 158.2 to 270.2 in the 2 % minoxidil group , from 156.6 to 287.0 in the 3 % minoxidil group , and from 162.6 to 246.9 in the placebo group . At month 12 the means were 415.6 , 448.5 , and 471.1 in the 2 % minoxidil , 3 % minoxidil , and placebo-3 % minoxidil crossover subjects , respectively . The increases from month 4 to month 12 were highly significant for each group ( p = 0.0001 ) . Average increases in nonvellus hair counts between months 4 and 12 were 216 , 181 , and 264 in the 2 % minoxidil , 3 % minoxidil , and placebo-to-3 % minoxidil crossover groups , respectively , all highly significant differences from zero ( p = 0.0001 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Fifty-eight men with Hamilton scale type III vertex or type IV male pattern baldness were studied to determine the dose-response activity of low concentrations of topical minoxidil in promoting hair growth . The patients were treated with topical minoxidil at doses of 0.01 % , 0.1 % , 1 % , or 2 % or placebo in a r and omized double-blind design for 6 months . At the end of 6 months , patients using 0.1 % , 1 % , and 2 % topical minoxidil solutions showed a significantly greater difference in the mean increase of nonvellus hair growth in comparison with those using 0.01 % minoxidil or placebo . There was a clear dose-response correlation for the increase of nonvellus hairs in the 0.1 % , 1 % , and 2 % minoxidil treatment groups . There was a statistically significant difference in patient 's self-evaluation of overall hair growth and degree of decreased hair shedding in the 1 % and 2 % minoxidil groups when compared with the other study groups . From this study we conclude that significant increases in nonvellus hair counts occur with 0.1 % and greater doses of minoxidil . However , only in patients treated with the 1 % and 2 % solutions of minoxidil was there clinical ly perceptible hair growth BACKGROUND Finasteride , a specific inhibitor of type II 5alpha-reductase , decreases serum and scalp dihydrotestosterone and has been shown to be effective in men with vertex male pattern hair loss . OBJECTIVE This study evaluated the efficacy of finasteride 1 mg/day in men with frontal ( anterior/mid ) scalp hair thinning . METHODS This was a 1-year , double-blind , placebo-controlled study followed by a 1-year open extension . Efficacy was assessed by hair counts ( 1 cm2 circular area ) , patient and investigator assessment s , and global photographic review . RESULTS There was a significant increase in hair count in the frontal scalp of finasteride-treated patients ( P < .001 ) , as well as significant improvements in patient , investigator , and global photographic assessment s. Efficacy was maintained or improved throughout the second year of the study . Finasteride was generally well tolerated . CONCLUSION In men with hair loss in the anterior/mid area of the scalp , finasteride 1 mg/day slowed hair loss and increased hair growth BACKGROUND To pical minoxidil solution 2 % stimulates new hair growth and helps stop the loss of hair in men with and rogenetic alopecia and women with female pattern hair loss . Results can be variable , and historic experience suggests that higher concentrations of topical minoxidil may enhance efficacy . OBJECTIVE The purpose of this 48-week , double-blind , placebo-controlled , r and omized , multicenter trial was to compare the efficacy and safety of 5 % topical minoxidil with 2 % topical minoxidil and placebo in the treatment of female pattern hair loss . METHODS A total of 381 women ( 18 - 49 years old ) with female pattern hair loss applied 5 % topical minoxidil solution ( n = 153 ) , 2 % topical minoxidil solution ( n = 154 ) , or placebo ( vehicle for 5 % solution ; n = 74 ) twice daily . Primary efficacy variables were change in nonvellus hair count at week 48 , and patient and investigator assessment s of change in hair growth/scalp coverage at week 48 . RESULTS After 48 weeks of therapy , 5 % topical minoxidil was superior to placebo for each of the 3 primary efficacy measures . The 2 % topical minoxidil group demonstrated superiority over placebo for hair count and investigator assessment of hair growth/scalp coverage at week 48 ; differences in patient assessment of hair growth at week 48 were not significantly different from placebo . The 5 % topical minoxidil group demonstrated statistical superiority over the 2 % topical minoxidil group in the patient assessment of treatment benefit at week 48 . Both 5 % and 2 % topical minoxidil helped improve psychosocial perceptions of hair loss in women with female pattern hair loss . An increased occurrence of pruritus , local irritation , and hypertrichosis was observed with 5 % topical minoxidil versus 2 % topical minoxidil and placebo . CONCLUSION In this 48-week study of 381 women with female pattern hair loss , 5 % topical minoxidil was superior to placebo on each of the 3 primary efficacy end points : promoting hair growth as measured by change in nonvellus hair count and patient/investigator assessment s of hair growth and scalp coverage . Application of 2 % topical minoxidil was superior to placebo for assessment s of nonvellus hair counts and investigator assessment of hair growth/scalp coverage at week 48 ; differences in patient assessment of hair growth at week 48 were not significantly different from placebo . At week 48 , the 5 % topical minoxidil group demonstrated statistical superiority over the 2 % topical minoxidil group in the patient assessment of treatment benefit . Both concentrations of topical minoxidil were well tolerated by the women in this trial without evidence of systemic adverse effects . With the introduction of numerous herbal remedies for hair loss , of which most have not been tested in r and omized , double-blind , placebo-controlled trials , it is important to describe well-controlled trials that demonstrate the efficacy and safety of topical drugs BACKGROUND Male pattern hair loss ( MPHL ) is a potentially reversible condition in which dihydrotestosterone is an important etiologic factor . OBJECTIVE Our aim was to evaluate the efficacy of the type 1 and 2 5alpha-reductase inhibitor dutasteride in men with MPHL . METHODS Four hundred sixteen men , 21 to 45 years old , were r and omized to receive dutasteride 0.05 , 0.1 , 0.5 or 2.5 mg , finasteride 5 mg , or placebo daily for 24 weeks . RESULTS Dutasteride increased target area hair count versus placebo in a dose-dependent fashion and dutasteride 2.5 mg was superior to finasteride at 12 and 24 weeks . Expert panel photographic review and investigator assessment of hair growth confirmed these results . Scalp and serum dihydrotestosterone levels decreased , and testosterone levels increased , in a dose-dependent fashion with dutasteride . LIMITATIONS The study was limited to 24 weeks . CONCLUSION Dutasteride increases scalp hair growth in men with MPHL . Type 1 and type 2 5alpha-reductase may be important in the pathogenesis and treatment of MPHL BACKGROUND Women generally regard their hair loss as socially unacceptable and go to great measures to conceal their problem . In some cases , the negative self-image brought about by hair loss may be the basis of psychiatric illness . The purpose of this study was to evaluate a 2 % topical minoxidil solution ( Rogaine/Regaine , The Upjohn Co , Kalamazoo , Mich ) for the treatment of female and rogenetic alopecia . A 32-week , double-blind , placebo-controlled trial was conducted in 11 US centers . Three hundred eight women with and rogenetic alopecia were enrolled . Two hundred fifty-six of these women completed the trial . A refined photographic technique was used to objective ly determine the number of nonvellus hairs regrown . RESULTS After 32 weeks of treatment , the number of nonvellus hairs in a 1-cm2 evaluation site was increased by an average of 23 hairs in the 2 % minoxidil group and by an average of 11 hairs in the placebo group . The 95 % confidence interval for the difference in mean hair count change between the treatment groups was 5.9 to 17.5 hairs . The investigators determined that 13 % in the minoxidil-treated group had moderate growth and 50 % had minimal growth . This compared with 6 % and 33 % , respectively , in the placebo-treated group . Similarly , 60 % of the patients in the 2 % minoxidil group reported that they had new hair growth ( 20 % moderate , 40 % minimal ) compared with 40 % ( 7 % moderate , 33 % minimal ) of the patients in the placebo group . No evaluations of dense hair growth were reported for either treatment group . No clinical ly significant changes in vital signs were observed and no serious or unexpected medical events were reported . CONCLUSIONS Topical minoxidil was significantly more effective than placebo in the treatment of female and rogenetic alopecia BACKGROUND Topical minoxidil solution 2 % stimulates new hair growth and helps stop the loss of hair in individuals with and rogenetic alopecia ( AGA ) . Results can be variable , and historical experience suggests that higher concentrations of topical minoxidil may enhance efficacy . OBJECTIVE The purpose of this 48-week , double-blind , placebo-controlled , r and omized , multicenter trial was to compare 5 % topical minoxidil with 2 % topical minoxidil and placebo in the treatment of men with AGA . METHODS A total of 393 men ( 18 - 49 years old ) with AGA applied 5 % topical minoxidil solution ( n = 157 ) , 2 % topical minoxidil solution ( n = 158 ) , or placebo ( vehicle for 5 % solution ; n = 78 ) twice daily . Efficacy was evaluated by scalp target area hair counts and patient and investigator assessment s of change in scalp coverage and benefit of treatment . RESULTS After 48 weeks of therapy , 5 % topical minoxidil was significantly superior to 2 % topical minoxidil and placebo in terms of change from baseline in nonvellus hair count , patient rating of scalp coverage and treatment benefit , and investigator rating of scalp coverage . Hair count data indicate that response to treatment occurred earlier with 5 % compared with 2 % topical minoxidil . Additionally , data from a patient question naire on quality of life , global benefit , hair growth , and hair styling demonstrated that 5 % topical minoxidil helped improve patients ' psychosocial perceptions of hair loss . An increased occurrence of pruritus and local irritation was observed with 5 % topical minoxidil compared with 2 % topical minoxidil . CONCLUSION In men with AGA , 5 % topical minoxidil was clearly superior to 2 % topical minoxidil and placebo in increasing hair regrowth , and the magnitude of its effect was marked ( 45 % more hair regrowth than 2 % topical minoxidil at week 48 ) . Men who used 5 % topical minoxidil also had an earlier response to treatment than those who used 2 % topical minoxidil . Psychosocial perceptions of hair loss in men with AGA were also improved . Topical minoxidil ( 5 % and 2 % ) was well tolerated by the men in this trial without evidence of systemic effects BACKGROUND Dutasteride Output:	Conclusions This meta‐ analysis strongly suggests that minoxidil , finasteride , and low‐level laser light therapy are effective for promoting hair growth in men with and rogenetic alopecia and that minoxidil is effective in women with and rogenetic alopecia .
MS2668	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Correctable weaknesses in the design , conduct , and analysis of biomedical and public health research studies can produce misleading results and waste valuable re sources . Small effects can be difficult to distinguish from bias introduced by study design and analyses . An absence of detailed written protocol s and poor documentation of research is common . Information obtained might not be useful or important , and statistical precision or power is often too low or used in a misleading way . Insufficient consideration might be given to both previous and continuing studies . Arbitrary choice of analyses and an overemphasis on r and om extremes might affect the reported findings . Several problems relate to the research workforce , including failure to involve experienced statisticians and method ologists , failure to train clinical research ers and laboratory scientists in research methods and design , and the involvement of stakeholders with conflicts of interest . Inadequate emphasis is placed on recording of research decisions and on reproducibility of research . Finally , reward systems incentivise quantity more than quality , and novelty more than reliability . We propose potential solutions for these problems , including improvements in protocol s and documentation , consideration of evidence from studies in progress , st and ardisation of research efforts , optimisation and training of an experienced and non-conflicted scientific workforce , and reconsideration of scientific reward systems Background The COSMIN checklist is a tool for evaluating the method ological quality of studies on measurement properties of health-related patient-reported outcomes . The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist ( n = 114 ) . Methods 75 articles evaluating measurement properties were r and omly selected from the bibliographic data base compiled by the Patient-Reported Outcome Measurement Group , Oxford , UK . Raters were asked to assess the method ological quality of three articles , using the COSMIN checklist . In a one-way design , percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item . Results 88 raters participated . Of the 75 selected articles , 26 articles were rated by four to six participants , and 49 by two or three participants . Overall , percentage agreement was appropriate ( 68 % was above 80 % agreement ) , and the kappa coefficients for the COSMIN items were low ( 61 % was below 0.40 , 6 % was above 0.75 ) . Reasons for low inter-rater agreement were need for subjective judgement , and accustom to different st and ards , terminology and definitions . Conclusions Results indicated that raters often choose the same response option , but that it is difficult on item level to distinguish between articles . When using the COSMIN checklist in a systematic review , we recommend getting some training and experience , completing it by two independent raters , and reaching consensus on one final rating . Instructions for using the checklist are improved OBJECTIVE The Derriford Appearance Scale ( DAS ) 59 was specifically design ed to measure psychosocial adjustment in patients with appearance problems . Previous studies using the DAS59 have proven it to be a reliable method of assessing the appearance-related quality of life after plastic surgery procedures . The aim of this study was to develop a valid and reliable Italian version of the DAS59 . PATIENTS AND METHODS The first Italian translation of this question naire was conducted according to the DAS59 protocol that was design ed by the original authors of the question naire . Eight hundred patients participated in this study and filled out three question naires ( DAS59 , General Health Question naire (GHQ)12 and Beck 's Depression Inventory (BDI)-II ) . There were 400 adult patients with a history of previous plastic surgeries and 400 adult patients without any personal history of previous plastic surgery procedures . A total of 50 patients were selected r and omly for test-retest analysis . RESULTS The overall internal consistency was excellent ( α = 0.95 ) and equal to that of the original article that first described the scale . There was a good correlation between all the items . Domains demonstrated good internal consistency ( Cronbach 's alpha ) and correlation within themselves . The construct validity of the Italian DAS59 was assessed under convergent validity that confirmed the correlation with scales related to other psychological conditions . GHQ12 showed relevant correlation with DAS59 , while BDI-II did not . CONCLUSIONS A valid and reliable Italian DAS59 version was developed that can be used for research and clinical assessment of patients with appearance problems and concerns , especially before and after plastic surgery procedures Objectives For the measurement of patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields OBJECTIVE To assess the reliability , validity and sensitivity to change of the Derriford Scale , a quality of life instrument design ed to assess the distress and dysfunction experienced by people who are self-conscious about their physical appearance . SUBJECTS AND DESIGN Postal question naire survey of 656 cosmetic surgery patients recruited from new referral letters and plastic surgery waiting list reports . A total of 443 subjects completed and returned the question naire . Of these respondents , 203 were sent a second question naire to assess reproducibility , of whom 155 subjects responded . MAIN OUTCOME MEASURES Reliability was assessed in terms of internal consistency and reproducibility . Face , content and construct validity were also investigated . RESULTS The analyses led to mixed results . There was some evidence of internal consistency , but a number of items had low endorsement levels and there may be scope for reducing the overall size of the instrument . When assessed for reproducibility , the level of agreement between scores of individuals completing the question naire on two occasions was high , but an important systematic shift in responses was also detected . Correlations between the other health status measures and the Derriford Scale provided some evidence of construct validity . CONCLUSION In its present form the Derriford Scale has good descriptive value , but there are some measurement problems identified in this report that need to be addressed before the scale is taken up into general use IMPORTANCE The impact of facial defects on quality of life as perceived by society and the value society places on facial reconstruction are important outcomes measures . OBJECTIVE To measure the health state utility and dollar value of surgically reconstructing facial defects as perceived by society . DESIGN , SETTING , AND PARTICIPANTS A r and omized observational study conducted in an academic tertiary referral center using a socioeconomically diverse group of 200 casual observers . MAIN OUTCOMES AND MEASURES Observers viewed images of faces with defects of varying sizes and locations before and after surgical reconstruction . Observers imagined if the defect in each image were on their own face and rated ( 1 ) their health state utility with the defect and ( 2 ) how much they would be willing to pay to have the defect surgically repaired to normal ( perfect repair ) . Established health state utility and contingent valuation metrics were used . RESULTS Data from 200 observers were analyzed . Facial defects significantly decreased perceived health state utility with the greatest penalty attributed to large and central ly located defects . Surgical reconstruction of the facial defects increased health state utility to near-normal ranges for all groups except large central defects . Participants were willing to pay an average of $ 1170 ( 95 % CI , $ 767-$1572 ) to repair a de novo small peripheral defect ; they were willing to pay $ 4274 more than the average ( 95 % CI , $ 3296-$5251 ) to repair a large defect and $ 2372 more ( 95 % CI , $ 1379-$3366 ) to repair a central defect . Using these valuation and health utility data , we calculated willingness to pay per quality -adjusted life-year ( WTP/QALY ) , a value-related metric . Mean WTP/QALY ratios ranged from $ 639/QALY for repairing small peripheral defects to $ 2838/QALY for repairing large central defects , well below all cost-effectiveness thresholds . CONCLUSIONS AND RELEVANCE Casual observers perceived that facial defects significantly decrease quality of life , an effect improved by reconstructive surgery . Measuring WTP and calculating WTP/QALY provides novel data to assess the social importance and value of facial reconstructive surgery . To our knowledge , these are the first data demonstrating that surgical reconstruction of facial defects is a high-value intervention as perceived by society . These findings have implication s for a broad range of stakeholders , including patients , surgeons , health policy makers , and payers . LEVEL OF EVIDENCE NA Background : The FACE-Q is a new patient-reported outcome instrument to evaluate a range of outcomes for patients undergoing any type of facial cosmetic operation , minimally invasive cosmetic procedure , or facial injectable . This article describes the development and validation of FACE-Q scales relevant to face-lift patients . Methods : The FACE-Q was developed by following international guidelines for patient-reported outcome instrument development . For outcomes following a face lift , the authors developed five appearance appraisal scales ( i.e. , Satisfaction with Cheeks , Satisfaction with Lower Face and Jawline , Appraisal of Nasolabial Folds , Appraisal of Area Under the Chin , and Appraisal of the Neck ) and an adverse effects checklist . A field test of these scales was performed in a sample of 225 face-lift patients , and were evaluated using both modern and traditional psychometric methods . Results : The five FACE-Q appearance appraisal scales were found to be clinical ly meaningful , reliable , valid , and responsive to clinical change . These findings were supported by Rasch measurement theory analysis ( e.g. , overall chi-square values of p ≥ 0.18 ; Person Separation Index ≥ 0.88 ) . Responsiveness analyses showed that patient scores for facial appearance improved significantly after treatment ( p < 0.001 ) ; changes in scores were associated with moderate effect sizes ( range effect size , 0.40 to 0.79 ; range st and ardized response mean , 0.37 to 0.69 ) . Traditional psychometric statistics provided further support ( e.g. , Cronbach ’s alpha values ≥0.94 ) Conclusions : The FACE-Q appearance appraisal scales are scientifically sound and clinical ly meaningful and can be used with the adverse effects checklist to measure patient-reported outcomes following a face lift . CLINICAL QUESTION /LEVEL OF EVIDENCE : Diagnostic , III OBJECTIVE To establish the clinical responsiveness of the Skin Cancer Index ( SCI ) , a new disease-specific quality of life ( QOL ) instrument , and to assess demographic and clinical factors which impact QOL in patients with nonmelanoma skin cancer ( NMSC ) . STUDY DESIGN Prospect i ve study of 183 patients with NMSC of the face and neck referred to a tertiary care Mohs surgery clinic . METHODS The SCI is a 15 item , vali date d , disease-specific QOL instrument with 3 distinct subscales , Emotion , Social , and Appearance . Higher scores reflect better QOL . The SCI and the Dermatology Life Quality Index ( DLQI ) , a general dermatology instrument , was administered at initial consultation and 4 months after surgical treatment . Multivariate analysis was conducted to assess demographic and clinical factors predictive of QOL for both instruments . RESULTS The SCI total score and all three subscale scores increased with treatment , demonstrating strong evidence of responsiveness over time ( P < .001 ) in contrast with the DLQI ( P = .46 ) . Predictors of poorer QOL for the SCI included female sex and cancers located on the lip . Patients who demonstrated greatest improvement in QOL with treatment included those who were younger ( < 50 yr ) and had lower reported household income . Also , first time NMSC patients and those patients who underwent less extensive reconstructions demonstrated greater improvements in QOL . CONCLUSION The SCI is a sensitive and responsive QOL instrument for patients with NMSC . Distinct demographic and clinical variables that impact QOL have been demonstrated using this multidimensional , disease-specific instrument OBJECTIVE To test 4 previously published outcomes instruments ( the Facelift Outcomes Evaluation , the Rhinoplasty Outcomes Evaluation , the Blepharoplasty Outcomes Evaluation , and the Skin Rejuvenation Outcomes Evaluation ) in terms of their reliability and validity in assessing patient-related outcomes of surgical intervention . DESIGN A prospect i ve pilot study of 78 patients in 3 similar private cosmetic surgery centers undergoing a total of 100 face-lift , rhinoplasty , blepharoplasty , and skin rejuvenation procedures . Patients were evaluated at 2 preoperative and 1 postoperative time points and the instruments were analyzed with regard to their test-retest reliability , internal consistency , and responsiveness to change . RES Output:	Conclusions : This is the first systematic review to identify and critically appraise patient-reported outcome measures for soft-tissue facial reconstruction using internationally accepted criteria . Through the use of psychometrically well-vali date d question naires , it is hoped that patients ’ concerns can be truly appreciated , the level of care improved , and the quality of reconstructive options offered advanced
MS2669	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract Background Adherence to prescribed medication is an imperative issue which can be directly linked with the management of chronic diseases like hypertension ; failure to adhere can affect the effectiveness of medication as well as the efficiency of the health care system . There is scarcity of information regarding the level of drug adherence for antihypertensive medications and its determinants in Ethiopia , particularly in the study area . Therefore , the aim of this study was to assess adherence level and its determinants for antihypertensive medications among adult hypertensive patients attending the chronic illness clinics of the referral hospitals in northwest Ethiopia . Methods Institution based cross sectional study was conducted from March to April , 2016 . The systematic r and om sampling technique was used to select 409 study participants from three referral hospitals . The question naire was prepared using the World Health Organization ( WHO ) conceptual model and by review ing international literature . The data were collected using an interviewer administered question naire . The data were entered in to Epi - Info version 7 and then transferred to the statistical package for social science ( SPSS ) version 20 for data cleaning and analysis .Bivariate analysis was first done to see the association between each independent variables and dependent variable . Variables with a P-value of less than 0.2 in the bivariate analysis were entered in to the multivariate logistic regression model for final analysis . Multivariate analysis was done using Backward logistic regression method . P-value less than 0.05 was considered to determine the statistical significance of the association and odds ratio with a 95 % confidence interval was used to determine the presence , strength , and direction of association between covariates ( explanatory variables ) and the outcome variable . The Morisky medication adherence scale was used to assess the adherence status using > = 6 as adherent or < 6 as non adherent score . Results Four hundred and nine ( 409 ) study participants were interviewed with a response rate of 100 % . The mean age of the respondents was 54.5 years with ( St and ard Deviation ( SD ) ± 13.58 ) . The overall rate of good adherence was 67.2 % ( 95 % CI = 62.8 , 71.6 ) . Participants who had a favourable attitude towards antihypertensive medications ( Adjusted odds ratio ( AOR ) = 9.88 , 95 % confidence interval ( CI ) : 5.34 , 18.27 ) , having good patient- provider relationship ( AOR = 4.25 , 95 % CI : 2.32 , 7.86 ) , having one ( AOR = 4.36 , 95 % CI : 1.34 , 14.12 ) or no ( AOR = 3.38 , 95 % CI:1.01,11.31 ) co-morbidities , a long duration of treatment ( AOR = 1.89 , 95%CI : 1.07 , 3.35 ) , and a low medical cost ( AOR = 2.06 , 95 % CI : 1.13 , 3.76 ) had associations with good drug adherence for antihypertensive medication/s . Conclusions The prevalence of good drug adherence for anti-hypertensive medications in this study was high . Prevention of co- morbidities , making medical services accessible , and maintaining good client-provider interaction are of paramount importance for good drug adherence Background : Adherence to hypertension management in patients with hypertension is known to influence their blood pressure control . It is important to measure patients ’ adherence behaviours to assist with design ing appropriate interventions to improve blood pressure control . Aims : The purpose s of this study were to use confirmatory factor analysis to revali date the Therapeutic Adherence Scale for Hypertensive Patients ( TASHP ) , and to calculate the cut-off score for classifying adherence behaviours into two groups : satisfactory and low adherence behaviours . Methods : Systematic r and om sampling was used to recruit patients with hypertension in China . Demographic characteristics , the TASHP and blood pressure were collected . The psychometric tests of the TASHP included : construct validity , criteria -related validity , internal reliability , and split-half reliability . The area under the receiver operating characteristics curve and Youden index were used to identify the cut-off score of the TASHP for blood pressure control . Results : This study involved 366 patients . Confirmatory factor analysis supported the four-component structure of the TASHP proposed in the original scale development study . The TASHP has a satisfactory internal reliability ( Cronbach ’s α > 0.7 ) and a satisfactory split-half reliability ( Spearman – Brown coefficients > 0.7 ) . The patients with overall scores of the TASHP ⩾ 109 points were considered to have satisfactory adherence behaviours . Conclusion : The TASHP is a vali date d and reliable instrument to measure the adherence to hypertension management in Chinese patients with hypertension . The cut-off score of 109 points can be considered as an effective measure to classify the level of adherence into satisfactory and low adherence behaviours Background The Morisky Medication Adherence scale ( MMAS-8 ) is a widely used self-reported measure of adherence to antihypertensive medications that has not been vali date d in hypertensive patients in sub-Saharan Africa . Methods We carried out a cross-sectional study to examine psychometric properties of a translated MMAS-8 ( MMAS-U ) in a tertiary care hypertension clinic in Ug and a. We administered the MMAS-U to consecutively selected hypertensive adults and used principal factor analysis and Cronbach ’s alpha to determine its validity and internal consistency respectively . Then we r and omly selected one-sixth of participants for a 2-week test-retest telephone interview . Lastly , we used ordinal logistic regression modeling to explore factors associated with levels of medication adherence . Results Of the 329 participants , 228 ( 69 % ) were females , median age of 55 years [ Interquartile range ( IQR ) ( 46–66 ) ] , and median duration of hypertension of 4 years [ IQR ( 2–8 ) ] . The adherence levels were low ( MMAS-U score ≤ 5 ) in 85 % , moderate ( MMAS-U score 6–7 ) in 12 % and high ( MMAS-U score ≥8 ) in 3 % . The factor analysis of construct validity was good ( overall Kaiser ’s measure of sampling adequacy for residuals of 0.72 ) and identified unidimensionality of MMAS-U. The internal consistency of MMAS-U was moderate ( Cronbach α = 0.65 ) , and test-retest reliability was low ( weighted kappa = 0.36 ; 95 % CI -0.01 , 0.73 ) . Age of 40 years or greater was associated with low medication adherence ( p = 0.02 ) whereas a family member buying medication for participants ( p = 0.02 ) and purchasing medication from a private clinic ( p = 0.02 ) were associated with high adherence . Conclusion The Ug and an version of the MMAS-8 ( MMAS-U ) is a valid and reliable measure of adherence to antihypertensive medication among Ug and an out patients receiving care at a public tertiary facility . Though the limited supply of medication affected adherence , this easy to use tool can be adapted to assess medication adherence among adults with hypertension in Ug and Background Medication adherence is an important predictor of optimal blood pressure control ; hence , it significantly reduces the risk of cardiovascular disease ( CVD ) and associated deaths . However , studies on medication adherence and its associated factors are scarce . Thus , this study aim ed to assess adherence to antihypertensive medications and identify associated factors at Debre Tabor General Hospital , northwest Ethiopia . Methods A hospital-based cross-sectional study was conducted . Simple r and om sampling technique was used to select 346 participants . A structured question naire adapted from the World Health Organization ( WHO ) STEPwise approach was used to collect data . Medication adherence was measured by the four-item Morisky – Green – Levine Scale , with a score ≥3 defined as “ good adherence ” . Data were entered using Epi Info version 7 and exported to SPSS version 20 for analysis . Descriptive and summary statistics were used . Bivariate and multivariable analyses were also carried out . Results A total of 337 hypertensive patients participated in the study . Three-quarters ( 75.1 % ) of the participants were found to be adherent to their medication therapy . The multivariable logistic regression analysis showed that urban residence ( adjusted odd ratio [AOR]=2.10 , 95 % confidence interval [ CI ] : 1.15 , 3.85 ) , taking less than two drugs per day ( AOR=3.04 , 95 % CI : 1.53 , 6.06 ) , and having knowledge about hypertension ( HTN ) and its treatment ( AOR=8.86 , 95 % CI : 4.67 , 16.82 ) were positively and significantly associated with medication adherence , while age > 60 years ( AOR=0.33 , 95 % CI : 0.11 , 0.98 ) was negatively and significantly associated with good medication adherence . Conclusion A significant proportion of hypertensive patients poorly adhere to antihypertensive medications . Age , residence , pill burden , and knowledge about HTN and its treatment are important predictors of medication adherence . Attention should be given to increase the knowledge of patients about their disease and its treatment , and due emphasis should also be given to older and rural patients Confirmation of medication adherence is a challenge in clinical practice and essential for the accurate diagnosis of resistant hypertension . Although it is well established that drug adherence is critical for controlling blood pressure , there are still difficulties applying a simple , inexpensive , and reliable assessment of adherence in the clinical setting . We aim ed to test a simple method to assess adherence in resistant hypertensive ( RH ) patients . A pilot study with normotensives or mild/moderate hypertensive subjects was performed to provide a fluorescence cutoff point for adherence . After that , 21 patients referred to the Resistant Hypertension Clinic had triamterene prescribed and were monitored for a 30-day period . We conducted two unannounced r and omly selected home visits for urine collection to test drug intake that day . Office , home and 24-hour ambulatory blood pressure , biochemical data , and the 8-item Morisky Medication Adherence Scale ( MMAS-8 ) were systematic ally acquired . According to adherence indicated by urine fluorescence , subjects were divided into adherent and nonadherent groups . We found 57 % of nonadherence . No differences were found between groups regarding baseline characteristics or prescribed medications ; Kappa 's test showed concordance between adherence through MMAS-8 items and fluorescence ( kappa = 0.61 ; 95 % confidence interval : 0.28 - 0.94 ; P = .005 ) . Nonadherent patients had higher office ( 81 ± 11 vs. 73 ± 6 mm Hg , P = .03 ) , 24-hour ambulatory blood pressure monitoring ( 75 ± 9 vs. 66 ± 7 mm Hg , P = .01 ) , and home blood pressure measurement ( 77 ± 9 vs. 67 ± 8 mm Hg , P = .01 ) diastolic blood pressure than their counterparts . Nonadherence to antihypertensive therapy is high in patients with RH , even when assessed in clinics specialized in this condition . Fluorometry to detect a drug in the urine of RH patients is safe , easy , and reliable method to assess adherence Output:	Conclusion : Medication adherence in the oldest old hypertensive patients seems to be higher than in younger persons . Adherence in older persons was associated with age , socioeconomic status , and therapy-related factors
MS2670	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE This r and omized , controlled noninferiority trial aim ed to compare the efficacy and safety of insulin detemir ( IDet ) versus neutral protamine Hagedorn ( NPH ) ( both with pr and ial insulin aspart ) in pregnant women with type 1 diabetes . RESEARCH DESIGN AND METHODS Patients were r and omized and exposed to IDet or NPH up to 12 months before pregnancy or at 8–12 weeks gestation . The primary analysis aim ed to demonstrate noninferiority of IDet to NPH with respect to A1C at 36 gestational weeks ( GWs ) ( margin of 0.4 % ) . The data were analyzed using linear regression , taking several baseline factors and covariates into account . RESULTS A total of 310 type 1 diabetic women were r and omized and exposed to IDet ( n = 152 ) or NPH ( n = 158 ) up to 12 months before pregnancy ( 48 % ) or during pregnancy at 8–12 weeks ( 52 % ) . The estimated A1C at 36 GWs was 6.27 % for IDet and 6.33 % for NPH in the full analysis set ( FAS ) . IDet was declared noninferior to NPH ( FAS , –0.06 % [ 95 % CI –0.21 to 0.08 ] ; per protocol , –0.15 % [ –0.34 to 0.04 ] ) . Fasting plasma glucose ( FPG ) was significantly lower with IDet versus NPH at both 24 GWs ( 96.8 vs. 113.8 mg/dL , P = 0.012 ) and 36 GWs ( 85.7 vs. 97.4 mg/dL , P = 0.017 ) . Major and minor hypoglycemia rates during pregnancy were similar between groups . CONCLUSIONS Treatment with IDet result ed in lower FPG and noninferior A1C in late pregnancy compared with NPH insulin . Rates of hypoglycemia were comparable OBJECTIVE To evaluate the progression of retinopathy during pregnancy and postpartum in ( insulin-dependent ) women with type 1 diabetes treated with insulin lispro or with regular human insulin . RESEARCH DESIGN AND METHODS A prospect i ve open study of 69 pregnant women with diabetes was performed . A total of 36 of the women were treated with insulin lispro ( lispro group ) and 33 were treated with conventional short-acting human insulin ( regular insulin group ) . The retinopathy level was estimated by color fundus photography every trimester and postpartum . Glycemic control during pregnancy , hypoglycemia ( blood glucose level <3 mmol/l ) in 24-h glucose profile , blood pressure , and proteinuria were registered . RESULTS HbA(1c ) values were similar at baseline in the first trimester but thereafter were lower in the lispro group than in the regular insulin group throughout pregnancy ( P = 0.022 , repeated- measures ANOVA ) . The number of hypoglycemic episodes did not differ between the treatment groups . In multivariable logistic regression analysis with retinopathy severity ( Diabetes Control and Complications Trial level ) in the third trimester as the dependent variable , only nulliparity qualified as a predictor in the model [ Exp(B ) = 4.0 , 95 % CI 1.1 - 13.7 , P = 0.030 ] . Factors such as duration of diabetes , type of insulin used , mean HbA(1c ) level throughout pregnancy , blood pressure ( systolic or diastolic ) , preeclampsia in the current pregnancy , smoking , or prepregnancy planning did not explain the retinopathy progression . CONCLUSIONS Insulin lispro improves glycemic control during diabetic pregnancy compared with regular insulin with no adverse impact on progression of diabetic retinopathy Background Women with hyperglycaemia detected during pregnancy are at greater risk for adverse pregnancy outcomes . Data on hyperglycaemia in pregnancy in sub-Saharan Africa is scanty and varied depending on the population s studied and the method ologies used to define hyperglycaemia in pregnancy . With the recent 2013 World Health Organisation ( WHO ) diagnostic criteria and classification , there is yet no sufficient data on the prevalence of hyperglycaemia in sub-Saharan Africa . The objective was to determine the prevalence of Hyperglycaemia first detected during pregnancy and subsequent obstetric outcomes among patients attending antenatal care ( ANC ) at St. Francis Hospital Nsambya . Methods A prospect i ve cohort study . All women with no history of diabetes mellitus attending at or after 24 weeks gestation were eligible to participate in the study . Participants underwent a st and ard 75 g oral glucose tolerance test ( OGTT ) after an informed written consent . The primary outcome was diagnosis of hyperglycaemia . Enrolled participants were followed up to delivery to assess obstetric outcomes ( secondary outcomes were birth weight , neonatal admission , maternal genital trauma , delivery mode , neonatal and maternal status at discharge ) . Results 251 women were screened between December 2013 and February 2014 . The prevalence of hyperglycaemia first detected in pregnancy was 31.9 % . We found 23.8 % of women with hyperglycaemia had no known risk factor . Macrosomia was the only obstetric outcome that was significantly associated with hyperglycaemia . Conclusion The prevalence of hyperglycaemia first detected in pregnancy was high in the studied population . Clinicians , therefore , should become more vigilant to screen for the condition . Selective screening may miss 23.8 % of pregnant women with hyperglycaemia . However the cost/benefit implication s of screening strategy and the recent 2013 WHO diagnostic criteria need to be studied in our setting OBJECTIVE —To assess the safety and efficacy of insulin aspart ( IAsp ) versus regular human insulin ( HI ) in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes . RESEARCH DESIGN AND METHODS —Subjects ( n = 322 ) who were pregnant or planning pregnancy were r and omized to IAsp or HI as meal-time insulin in an open-label , parallel-group , multicenter study . Subjects had A1C ≤8 % at confirmation of pregnancy . Insulin doses were titrated toward predefined glucose targets and A1C < 6.5 % . Outcomes assessed included risk of major maternal hypoglycemia , A1C , plasma glucose profiles , and maternal safety outcomes . RESULTS —Major hypoglycemia occurred at a rate of 1.4 vs. 2.1 episodes/year exposure with IAsp and HI , respectively ( relative risk 0.720 [ 95 % CI 0.36–1.46 ] ) . Risk of major/major nocturnal hypoglycemia was 52 % ( RR 0.48 [ 0.20–1.143 ] ; P = NS ) lower with IAsp compared with HI . A1C was comparable with human insulin in second ( IAsp-HI −0.04 [ −0.18 to 0.11 ] ) and third ( −0.08 [ −0.23 to 0.06 ] ) trimesters . A total of 80 % of subjects achieved an A1C ≤6.5 % . At the end of first and third trimesters , average postpr and ial plasma glucose increments were significantly lower with IAsp than HI ( P = 0.003 and P = 0.044 , respectively ) , as were mean plasma glucose levels 90 min after breakfast ( P = 0.044 and P = 0.001 , respectively ) . Maternal safety profiles and pregnancy outcomes were similar between treatments . CONCLUSIONS —IAsp is at least as safe and effective as HI when used in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes and may potentially offer some benefits in terms of postpr and ial glucose control and preventing severe hypoglycemia Objective . To describe perinatal outcomes of women with pregestational diabetes treated with short-acting , regular insulin and the short-acting insulin analogue , lispro . Study design . This was a prospect i ve observational study of women with pregestational diabetes maintained on short-acting insulin regimens over a 3-year period . Clinical characteristics , aspects of diabetic therapy , and perinatal/neonatal outcomes were collected . Results . Of 107 women , 49 were maintained on regular insulin and 58 utilized the insulin analogue , lispro . Frequency of type 1 diabetes , maternal age , overweight/obese pregravid body mass index ( ≥25 kg/m2 ) , preexisting hypertension , and presence of vascular disease were similar between groups . Women treated with lispro had a longer duration of diabetes ( 11.4 vs. 8.3 years , p = 0.04 ) . Glycemic control was improved in women managed with lispro compared to regular insulin ( HgbA1c 5.9 vs. 6.7 , p = 0.009 ) . Total insulin requirements were lower in the lispro group in the first ( 0.58 vs. 0.79 units/kg , p = 0.02 ) , second ( 0.75 vs. 1.10 units/kg , p = 0.002 ) , and third ( 0.98 vs. 1.25 units/kg , p = 0.03 ) trimesters of pregnancy . Mean infant birth weight was greater in the lispro group , whereas the rate of large for gestational age infants and ponderal indices were similar between groups . Malformation rate , gestational age at delivery , neonatal intensive care unit admission , neonatal length of stay , rates of respiratory distress syndrome , and hypoglycemia were similar . Conclusions . Women treated with lispro demonstrated improved glycemic control and lower total insulin requirements during pregnancy compared to those receiving regular insulin . Perinatal outcomes were similar between women treated with both types of insulin Objective To investigate maternal , perinatal , and neonatal outcomes of pregnancies in women with type 1 diabetes in the Netherl and s. Design Nationwide prospect i ve cohort study . Setting All 118 hospitals in the Netherl and s. Participants 323 women with type 1 diabetes who became pregnant between 1 April 1999 and 1 April 2000 . Main outcome measures Maternal , perinatal , and neonatal outcomes of pregnancy . Results 84 % ( n = 271 ) of the pregnancies were planned . Glycaemic control early in pregnancy was good in most women ( HbA1c  7.0 % in 75 % ( n = 212 ) of the population ) , and folic acid supplementation was adequate in 70 % ( n = 226 ) . 314 pregnancies that went beyond 24 weeks ' gestation result ed in 324 infants . The rates of pre-eclampsia ( 40 ; 12.7 % ) , preterm delivery ( 101 ; 32.2 % ) , caesarean section ( 139 ; 44.3 % ) , maternal mortality ( 2 ; 0.6 % ) , congenital malformations ( 29 ; 8.8 % ) , perinatal mortality ( 9 ; 2.8 % ) , and macrosomia ( 146 ; 45.1 % ) were considerably higher than in the general population . Neonatal morbidity ( one or more complications ) was extremely high ( 260 ; 80.2 % ) . The incidence of major congenital malformations was significantly lower in planned pregnancies than in unplanned pregnancies ( 4.2 % ( n = 11 ) v 12.2 % ( n = 6 ) ; relative risk 0.34 , 95 % confidence interval 0.13 to 0.88 ) . Conclusion Despite a high frequency of planned pregnancies , result ing in overall good glycaemic control ( early ) in pregnancy and a high rate of adequate use of folic acid , maternal and perinatal complications were still increased in women with type 1 diabetes . Neonatal morbidity , especially hypoglycaemia , was also extremely high . Near optimal maternal glycaemic control ( HbA1c  7.0 % ) apparently is not good enough BACKGROUND Improved blood-glucose control decreases the progression of diabetic microvascular disease , but the effect on macrovascular complications is unknown . There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation . We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a r and omised controlled trial . METHODS 3867 newly diagnosed patients with type 2 diabetes , median age 54 years ( IQR 48 - 60 years ) , who after 3 months ' diet treatment had a mean of two fasting plasma glucose ( FPG ) concentrations of 6.1 - 15.0 mmol/L were r and omly assigned int Output:	This result , in the clinical practice , does not compromise the fetal well-being , since all babies were born at term . To date , the evidence analyzed has a moderate-to-high risk of bias and does not allow the conclusion that insulin analogs are more effective when compared with human insulin to treat diabetic pregnant women
MS2671	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective : To assess the efficacy and safety of modafinil for the treatment of fatigue in multiple sclerosis ( MS ) . Methods : Patients aged 18–65 years with a diagnosis of MS , a stable disability level ≤6 on the Kurtzke extended disability status scale ( EDSS ) , and a mean score > 4 on the fatigue severity scale ( FSS ) were eligible for the 9 week , single blind , phase 2 , two centre study . Exclusion criteria included a diagnosis of narcolepsy , sleep apnoea , or clinical ly significant major systemic disease and recent use of medications affecting fatigue . All patients , who remained blinded for the treatment regimen , received placebo during weeks 1–2 , 200 mg/day modafinil during weeks 3–4 , 400 mg/day modafinil during weeks 5–6 , and placebo during weeks 7–9 . Safety was evaluated by unblinded investigators . Efficacy was evaluated by self rating scales , using the FSS , the modified fatigue impact scale ( MFIS ) , a visual analogue scale for fatigue ( VAS-F ) , and the Epworth sleepiness scale ( ESS ) . Adverse events were recorded . Results : Seventy two patients ( MS type : 74 % relapsing-remitting ; 7 % primary progressive ; 19 % secondary progressive ) received treatment . After treatment with 200 mg/day modafinil for 2 weeks , a significant improvement in fatigue versus placebo run in was demonstrated . Mean scores after treatment with 200 mg/day modafinil were : FSS , 4.7 versus 5.5 for placebo ( p<0.001 ) ; MFIS , 37.7 versus 44.7 ( p<0.001 ) ; and VAS-F , 5.4 versus 4.5 ( p=0.003 ) . Fatigue scores for 400 mg/day modafinil were not significantly improved versus placebo run in . Mean ESS scores were significantly improved ( p<0.001 ) with 200 mg/day modafinil ( 7.2 ) and 400 mg/day ( 7.0 ) versus the score at baseline ( 9.5 ) . Serious adverse events were not found at either dose . The most common adverse events were headache , nausea , and aesthenia . Sixty five patients ( 90 % ) completed the study . Conclusions : These data suggest that 200 mg/day modafinil significantly improves fatigue and is well tolerated in patients with MS BACKGROUND Centenarians are characterized by weakness , decreasing mental health , impaired mobility , and poor endurance . L-Carnitine is an important contributor to cellular energy metabolism . OBJECTIVE This study evaluated the efficacy of L-carnitine on physical and mental fatigue and on cognitive functions of centenarians . DESIGN This was a placebo-controlled , r and omized , double-blind , 2-phase study . Sixty-six centenarians with onset of fatigue after even slight physical activity were recruited to the study . The 2 groups received either 2 g levocarnitine once daily ( n = 32 ) or placebo ( n = 34 ) . Efficacy measures included changes in total fat mass , total muscle mass , serum triacylglycerol , total cholesterol , HDL cholesterol , LDL cholesterol , Mini-Mental State Examination ( MMSE ) , Activities of Daily Living , and a 6-min walking corridor test . RESULTS At the end of the study period , the levocarnitine-treated centenarians , compared with the placebo group , showed significant improvements in the following markers : total fat mass ( -1.80 compared with 0.6 kg ; P < 0.01 ) , total muscle mass ( 3.80 compared with 0.8 kg ; P < 0.01 ) , plasma concentrations of total carnitine ( 12.60 compared with -1.70 mumol ; P < 0.05 ) , plasma long-chain acylcarnitine ( 1.50 compared with -0.1 micromol ; P < 0.001 ) , and plasma short-chain acylcarnitine ( 6.0 compared with -1.50 micromol ; P < 0.001 ) . Significant differences were also found in physical fatigue ( -4.10 compared with -1.10 ; P < 0.01 ) , mental fatigue ( -2.70 compared with 0.30 ; P < 0.001 ) , fatigue severity ( -23.60 compared with 1.90 ; P < 0.001 ) , and MMSE ( 4.1 compared with 0.6 ; P < 0.001 ) . CONCLUSIONS Our study indicates that oral administration of levocarnitine produces a reduction of total fat mass , increases total muscular mass , and facilitates an increased capacity for physical and cognitive activity by reducing fatigue and improving cognitive functions Nutritional factors and comedications are among the postulated causes of fatigue , a highly prevalent symptom in the multiple sclerosis ( MS ) population , with serious impact on patients ’ quality of life . Deficiency of carnitine may play a role by reducing energy production through fatty acid oxidation and numerous MS therapies can induce fatigue syndrome . The aim of this prospect i ve open-labelled study was to collect and study serum carnitine levels in MS patients with and without disease-modifying treatment-induced fatigue syndrome . We investigated whether restoration of the carnitine pool might improve treatment-induced fatigue in MS patients . In our study , there was no statistical difference in fatigue frequency between treated and untreated patients ( P=0.5 ) . Matched to age , gender and treatments , carnitine levels were lower for MS treated patients compared to untreated MS patients ( P<0.05 ) or controls ( P<0.001 ) . Consecutive patients with low plasma carnitine levels who experienced fatigue were substituted . Treatment consisted of oral levocarnitine , 3 - 6 g daily . All patients achieved normal plasma carnitine levels . For 63 % of patients treated with immunosuppressive or immunomodulatory therapies , oral levocarnitine adjunction decreased fatigue intensity , especially in patients treated with cyclophosphamide and interferon beta We carried out a double blind control study of fatigue in 32 patients with multiple sclerosis , comparing amantadine hydrochloride 100 mg twice a day and placebo . On amantadine 31 % had marked improvement ; 15.6 % moderate improvement ; 15.6 % mild improvement ; and 36.5 % unchanged . On placebo , none noted marked improvement ; one cl aim ed moderate improvement on either amantadine or placebo . 18.7 % reported mild improvement on placebo ; and most of them had similar or more response to amantadine . No patient selected placebo over amantadine at the end of the trial . Overall improvement was seen in 62.5 % of patients on amantadine and 21.8 % on placebo . Additional experience up to two years suggests continued benefit but common and important side-effects Aim Levocarnitine is an important contributor to cellular energy metabolism . This study aims to evaluate the effects of levocarnitine supplementation on body composition , lipid profile and fatigue in elderly subjects with rapid muscle fatigue . Method This was a placebo-controlled , r and omised , double-blind , two-phase study . Eighty-four elderly subjects with onset of fatigue following slight physical activity were recruited to the study . Prior to r and omisation all patients entered a 2-week normalisation phase where they were given an ‘ ad libitum ’ diet , according to the National Cholesterol Education Program ( Step 2 ) . Subjects were asked to record their daily food intake every 2 days . Before the 30-day treatment phase , subjects were r and omly assigned to two groups ( matched for male/female ratio , age and body mass index ) . One group received levocarnitine 2 g twice daily ( n = 42 ) and the other placebo ( n = 42 ) . Efficacy measures included changes in total fat mass , total muscle mass , serum triglyceride , total cholesterol , high-density lipoprotein-cholesterol ( HDL-C ) , low-density lipoprotein-cholesterol ( LDL-C ) , apolipoprotein (apo)A1 , and apoB levels . The Wessely and Powell scale was used to evaluate physical and mental fatigue . Subjects were assessed at the beginning and end of the study period . Results At the end of the study , compared with placebo , the levocarnitine-treated patients showed significant improvements in the following parameters : total fat mass ( −3.1 vs −0.5 kg ) , total muscle mass ( + 2.1 vs + 0.2 kg ) , total cholesterol ( −1.2 vs + 0.1 mmol/L ) , LDL-C ( −1.1 vs −0.2 mmol/L ) , HDL-C ( + 0.2 vs + 0.01 mmol/ L ) , triglycerides ( −0.3 vs 0.0 mmol/L ) , apoA1 ( −0.2 vs 0.0 g/L ) , and apoB ( −0.3 vs −0.1 g/L ) . Wessely and Powell scores decreased significantly by 40 % ( physical fatigue ) and 45 % ( mental fatigue ) in subjects taking levocarnitine , compared with 11 % and 8 % , respectively , in the placebo group ( p < 0.001 vs placebo for both parameters ) . No adverse events were reported in any treatment group . Conclusion Administration of levocarnitine to healthy elderly subjects result ed in a reduction of total fat mass , an increase of total muscle mass , and appeared to exert a favourable effect on fatigue and serum lipids Background Modafinil is a unique wake-promoting agent that is chemically distinct from traditional stimulants . Results of a placebo-controlled study showed it to improve fatigue in multiple sclerosis ( MS ) at a dose of 200 mg daily , but not at a dose of 400 mg daily . Objective To establish the efficacy , safety and appropriate dose of modafinil in the treatment of fatigue and sleepiness in patients with multiple sclerosis . Method A total of 50 patients diagnosed with MS ( mean age 40.4 ± 10.3 years , 30 females/20 males ; MS type : 36 relapsing remitting , 1 primary progressive , 13 secondary progressive ; mean disability level 3.8 ± 1.5 on the Kurtzke EDSS ) and complaining of chronic fatigue were enrolled in a prospect i ve 3-month , two-center , open-label study . Efficacy was evaluated with the Fatigue Severity Scale ( FSS , score range 0 - 42 ) , the Epworth Sleepiness Scale ( ESS , score range 0 - 24 ) and by subjective patient appraisal of change of fatigue , quality of life and overall satisfaction with treatment . Adverse effects ( AEs ) were recorded throughout the study . Treatment was started with a single daily dose of 100 mg in all patients . In non-responders the dose was increased by 100 mg increments up to a maximum daily dose of 400 mg . Results Three patients discontinued modafinil because of AEs ( nervousness , dizziness ) . Two patients ( 4 % ) were treated with 50 mg , 25 ( 50 % ) with 100 mg , 21 ( 42 % ) with 200 mg and 2 ( 4 % ) with 300 mg daily . No patient required 400 mg daily . Mean FSS scores were 30.3 ± 8.5 at baseline and 25.4 ± 3.7 at 3 months ( p < 0.0001 ) . Mean ESS scores were 9.7 ± 3.9 at baseline and 4.9 ± 2.9 at 3 months ( p < 0.0001 ) . Self- appraisal of change of fatigue showed clear improvement in 41 patients ( 87.2 % ) , some improvement in 4 ( 8.5 % ) and no change in 2 ( 4.3 % ) . Overall clinical condition was clearly improved in 43 patients ( 91.5 % ) , somewhat improved in 1 patient ( 2.1 % ) , and unchanged in 3 patients ( 6.4 % ) . No patient reported worsening of overall clinical condition . Conclusions Treatment with modafinil significantly improves fatigue and sleepiness and is well tolerated by patients with MS . Unlike the higher dose regimen required in narcolepsy , a low-dose regimen of modafinil is effective in MS Multiple sclerosis ( MS ) patients of an inpatient rehabilitation program have been r and omly assigned to an exercise training ( MS-ET ) or nontraining group ( MS-NI ) . Before and after 4 weeks of aerobic exercise training , a grade d maximal exercise test with measurement of gas exchange and a lung function test was administered to all 26 patients fulfilling the inclusion criteria . Activity level , fatigue and health perception were measured by means of question naires . Twenty-six healthy persons served as control group and were matched in respect of age , gender and activity level . Training intervention consisted of 5 × 30 min sessions per week of bicycle exercise with individualised intensity . Compared with baseline , the MS training group demonstrated a significant rightward placement of the aerobic threshold ( AT ) ( VO2 + 13 % ; work rate [WR])+11 % ) , an improvement of health perception ( vitality+46 % ; social interaction+36 % ) , an increase of activity level ( + 17 % ) and a tendency to less fatigue . No changes were observed for the MS-NI group and the control groups . Maximal aerobic capacity Output:	There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators
MS2672	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Mild cognitive impairment ( MCI ) is a well-recognised risk factor for dementia and represents a vital opportunity for intervening . Exercise is a promising strategy for combating cognitive decline by improving brain structure and function . Specifically , aerobic training ( AT ) improved spatial memory and hippocampal volume in healthy community-dwelling older adults . In older women with probable MCI , we previously demonstrated that resistance training ( RT ) and AT improved memory . In this secondary analysis , we investigated : ( 1 ) the effect of RT and AT on hippocampal volume and ( 2 ) the association between change in hippocampal volume and change in memory . Methods 86 women aged 70–80 years with probable MCI were r and omly assigned to a 6-month , twice-weekly programme of : ( 1 ) AT , ( 2 ) RT or ( 3 ) balance and tone training ( BAT ; ie , control ) . At baseline and trial completion , participants performed a 3 T MRI scan to determine hippocampal volume . Verbal memory and learning were assessed by Rey 's Auditory Verbal Learning Test . Results Compared with the BAT group , AT significantly improved left , right and total hippocampal volumes ( p≤0.03 ) . After accounting for baseline cognitive function and experimental group , increased left hippocampal volume was independently associated with reduced verbal memory and learning performance as indexed by loss after interference ( r=0.42 , p=0.03 ) . Conclusions Aerobic training significantly increased hippocampal volume in older women with probable MCI . More research is needed to ascertain the relevance of exercise-induced changes in hippocampal volume on memory performance in older adults with MCI . Trail registration number NCT00958867 Background To examine the effect of multicomponent exercise program on memory function in older adults with mild cognitive impairment ( MCI ) , and identify biomarkers associated with improvement of cognitive functions . Methodology /Principal Findings Subjects were 100 older adults ( mean age , 75 years ) with MCI . The subjects were classified to an amnestic MCI group ( n = 50 ) with neuroimaging measures , and other MCI group ( n = 50 ) before the r and omization . Subjects in each group were r and omized to either a multicomponent exercise or an education control group using a ratio of 1∶1 . The exercise group exercised for 90 min/d , 2 d/wk , 40 times for 6 months . The exercise program was conducted under multitask conditions to stimulate attention and memory . The control group attended two education classes . A repeated- measures ANOVA revealed that no group × time interactions on the cognitive tests and brain atrophy in MCI patients . A sub- analysis of amnestic MCI patients for group × time interactions revealed that the exercise group exhibited significantly better Mini-Mental State Examination ( p = .04 ) and logical memory scores ( p = .04 ) , and reducing whole brain cortical atrophy ( p<.05 ) compared to the control group . Low total cholesterol levels before the intervention were associated with an improvement of logical memory scores ( p<.05 ) , and a higher level of brain-derived neurotrophic factor was significantly related to improved ADAS-cog scores ( p<.05 ) . Conclusions / Significance The results suggested that an exercise intervention is beneficial for improving logical memory and maintaining general cognitive function and reducing whole brain cortical atrophy in older adults with amnestic MCI . Low total cholesterol and higher brain-derived neurotrophic factor may predict improvement of cognitive functions in older adults with MCI . Further studies are required to determine the positive effects of exercise on cognitive function in older adults with MCI . Trial Registration UMIN-CTR UMIN000003662 ctr.cgi?function = brows&action = brows&type = summary & recptno = R000004436 & language = BACKGROUND The present study examined whether aerobic fitness training of older humans can increase brain volume in regions associated with age-related decline in both brain structure and cognition . METHODS Fifty-nine healthy but sedentary community-dwelling volunteers , aged 60 - 79 years , participated in the 6-month r and omized clinical trial . Half of the older adults served in the aerobic training group , the other half of the older adults participated in the toning and stretching control group . Twenty young adults served as controls for the magnetic resonance imaging ( MRI ) , and did not participate in the exercise intervention . High spatial resolution estimates of gray and white matter volume , derived from 3D spoiled gradient recalled acquisition MRI images , were collected before and after the 6-month fitness intervention . Estimates of maximal oxygen uptake ( VO2 ) were also obtained . RESULTS Significant increases in brain volume , in both gray and white matter regions , were found as a function of fitness training for the older adults who participated in the aerobic fitness training but not for the older adults who participated in the stretching and toning ( nonaerobic ) control group . As predicted , no significant changes in either gray or white matter volume were detected for our younger participants . CONCLUSIONS These results suggest that cardiovascular fitness is associated with the sparing of brain tissue in aging humans . Furthermore , these results suggest a strong biological basis for the role of aerobic fitness in maintaining and enhancing central nervous system health and cognitive functioning in older adults The hippocampus shrinks in late adulthood , leading to impaired memory and increased risk for dementia . Hippocampal and medial temporal lobe volumes are larger in higher-fit adults , and physical activity training increases hippocampal perfusion , but the extent to which aerobic exercise training can modify hippocampal volume in late adulthood remains unknown . Here we show , in a r and omized controlled trial with 120 older adults , that aerobic exercise training increases the size of the anterior hippocampus , leading to improvements in spatial memory . Exercise training increased hippocampal volume by 2 % , effectively reversing age-related loss in volume by 1 to 2 y. We also demonstrate that increased hippocampal volume is associated with greater serum levels of BDNF , a mediator of neurogenesis in the dentate gyrus . Hippocampal volume declined in the control group , but higher preintervention fitness partially attenuated the decline , suggesting that fitness protects against volume loss . Cau date nucleus and thalamus volumes were unaffected by the intervention . These theoretically important findings indicate that aerobic exercise training is effective at reversing hippocampal volume loss in late adulthood , which is accompanied by improved memory function The objective of this study was to examine exercise effects on global brain volume , hippocampal volume , and cortical thickness in schizophrenia patients and healthy controls . Irrespective of diagnosis and intervention , associations between brain changes and cardiorespiratory fitness improvement were examined . Sixty-three schizophrenia patients and fifty-five healthy controls participated in this r and omised controlled trial . Global brain volumes , hippocampal volume , and cortical thickness were estimated from 3-Tesla MRI scans . Cardiorespiratory fitness was assessed with a cardiopulmonary ergometer test . Subjects were assigned exercise therapy or occupational therapy ( patients ) and exercise therapy or life-as-usual ( healthy controls ) for six months 2h weekly . Exercise therapy effects were analysed for subjects who were compliant at least 50 % of sessions offered . Significantly smaller baseline cerebral ( grey ) matter , and larger third ventricle volumes , and thinner cortex in most areas of the brain were found in patients versus controls . Exercise therapy did not affect global brain and hippocampal volume or cortical thickness in patients and controls . Cardiorespiratory fitness improvement was related to increased cerebral matter volume and lateral and third ventricle volume decrease in patients and to thickening in the left hemisphere in large areas of the frontal , temporal and cingulate cortex irrespective of diagnosis . One to 2h of exercise therapy did not elicit significant brain volume changes in patients or controls . However , cardiorespiratory fitness improvement attenuated brain volume changes in schizophrenia patients and increased thickness in large areas of the left cortex in both schizophrenia patients and healthy controls Cardiovascular fitness is thought to offset declines in cognitive performance , but little is known about the cortical mechanisms that underlie these changes in humans . Research using animal models shows that aerobic training increases cortical capillary supplies , the number of synaptic connections , and the development of new neurons . The end result is a brain that is more efficient , plastic , and adaptive , which translates into better performance in aging animals . Here , in two separate experiments , we demonstrate for the first time to our knowledge , in humans that increases in cardiovascular fitness results in increased functioning of key aspects of the attentional network of the brain during a cognitively challenging task . Specifically , highly fit ( Study 1 ) or aerobically trained ( Study 2 ) persons show greater task-related activity in regions of the prefrontal and parietal cortices that are involved in spatial selection and inhibitory functioning , when compared with low-fit ( Study 1 ) or nonaerobic control ( Study 2 ) participants . Additionally , in both studies there exist groupwise differences in activation of the anterior cingulate cortex , which is thought to monitor for conflict in the attentional system , and signal the need for adaptation in the attentional network . These data suggest that increased cardiovascular fitness can affect improvements in the plasticity of the aging human brain , and may serve to reduce both biological and cognitive senescence in humans Cardiovascular activity has been shown to be positively associated with gray and white matter volume of , amongst others , frontal and temporal brain regions in older adults . This is particularly true for the hippocampus , a brain structure that plays an important role in learning and memory , and whose decline has been related to the development of Alzheimer ’s disease . In the current study , we were interested in whether not only cardiovascular activity but also other types of physical activity , i.e. , coordination training , were also positively associated with the volume of the hippocampus in older adults . For this purpose we first collected cross-sectional data on “ metabolic fitness ” ( cardiovascular fitness and muscular strength ) and “ motor fitness ” ( e.g. , balance , movement speed , fine coordination ) . Second , we performed a 12-month r and omized controlled trial . Results revealed that motor fitness but not metabolic fitness was associated with hippocampal volume . After the 12-month intervention period , both , cardiovascular and coordination training led to increases in hippocampal volume . Our findings suggest that a high motor fitness level as well as different types of physical activity were beneficial to diminish age-related hippocampal volume shrinkage or even increase hippocampal volume We present a general method for automatic meta-analyses in neuroscience and apply it on text data from published functional imaging studies to extract main functions associated with a brain area-the posterior cingulate cortex ( PCC ) . Abstract s from PubMed are downloaded , words extracted and converted to a bag-of-words matrix representation . The combined data are analyzed with hierarchical non-negative matrix factorization . We find that the prominent themes in the PCC corpus are episodic memory retrieval and pain . We further characterize the distribution in PCC of the Talairach coordinates available in some of the articles . This shows a tendency to functional segregation between memory and pain components where memory activations are predominantly in the caudal part and pain in the rostral part of PCC Exercise is considered an important component of a healthy lifestyle but there remains controversy on effects of exercise on non-exercise physical activity ( PA ) . The present study examined the prospect i ve association of aerobic and resistance exercise with total daily energy expenditure and PA in previously sedentary , young men . Nine men ( 27.0 ± 3.3 years ) completed two 16-week exercise programs ( 3 exercise sessions per week ) of aerobic and resistance exercise separated by a minimum of 6 weeks in r and om order . Energy expenditure and PA were measured with the SenseWear Mini Armb and prior to each intervention as well as during week 1 , week 8 and week 16 of the aerobic and resistance exercise program . Body composition was measured via dual x-ray absorptiometry . Body composition did not change in response to either exercise intervention . Total daily energy expenditure on exercise days increased by 443 ± 126 kcal/d and 239 ± 152 kcal/d for aerobic and resistance exercise , respectively ( p < 0.01 ) . Non-exercise moderate-to-vigorous PA , however , decreased on aerobic exercise days ( −148 ± 161 kcal/d ; p = 0.03 ) . There was no change in total daily energy expenditure and PA on non-exercise days with aerobic exercise while resistance exercise was associated with an increase in moderate-to-vigorous PA during non-exercise days ( 216 ± 178 kcal/d , p = 0.01 ) . Results of the present study suggest a compensatory reduction in PA in response to aerobic exercise . Resistance exercise , on the other h and , appears to facilitate non-exercise PA , particularly on non-exercise days , which may lead to more sustainable adaptations in response to an exercise program BACKGROUND The hippocampal volume is reduced in patients with major depression . Exercise leads to an increased hippocampal volume in schizophrenia and in healthy old adults . The effect of exercise on hippocampal volume is potentially mediated by brain derived neurotrophic factor ( BDNF ) , vascular endothelial growth factor ( VEGF ) , and insulin like growth factor 1 ( IGF-1 ) . The aim of this trial was to assess the effect of an aerobic exercise intervention on hippocampal volume and serum BDNF , VEGF , and IGF-1 in patients with major depression . METHODS Patients were r and omized to Output:	A few studies reported that relative to no-exercise interventions , aerobic exercise could significantly decrease the atrophy of the medial temporal lobe , slow the anterior cingulate cortex ( ACC ) volume loss , increase functional connectivity within the hippocampus and improve signal activation in the cingulate gyrus and ACC . The current review suggests that aerobic exercise may have positive effects on the right hippocampus and potentially beneficial effects on the overall and other parts of the hippocampus , the cingulate cortex and the medial temporal areas of the DMN . Moreover , aerobic exercise may increase functional connectivity or activation in the hippocampus , cingulate cortex and parahippocampal gyrus regions of the DMN .
MS2673	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Recent studies suggest that delirium is associated with risk of dementia and also acceleration of decline in existing dementia . However , previous studies may have been confounded by incomplete ascertainment of cognitive status at baseline . Herein , we used a true population sample to determine if delirium is a risk factor for incident dementia and cognitive decline . We also examined the effect of delirium at the pathological level by determining associations between dementia and neuropathological markers of dementia in patients with and without a history of delirium . The Vantaa 85 + study examined 553 individuals ( 92 % of those eligible ) aged ≥85 years at baseline , 3 , 5 , 8 and 10 years . Brain autopsy was performed in 52 % . Fixed and r and om-effects regression models were used to assess associations between ( i ) delirium and incident dementia and ( ii ) decline in Mini-Mental State Examination scores in the whole group . The relationship between dementia and common neuropathological markers ( Alzheimer-type , infa rcts and Lewy-body ) was modelled , stratified by history of delirium . Delirium increased the risk of incident dementia ( odds ratio 8.7 , 95 % confidence interval 2.1–35 ) . Delirium was also associated with worsening dementia severity ( odds ratio 3.1 , 95 % confidence interval 1.5–6.3 ) as well as deterioration in global function score ( odds ratio 2.8 , 95 % confidence interval 1.4–5.5 ) . In the whole study population , delirium was associated with loss of 1.0 more Mini-Mental State Examination points per year ( 95 % confidence interval 0.11–1.89 ) than those with no history of delirium . In individuals with dementia and no history of delirium ( n = 232 ) , all pathologies were significantly associated with dementia . However , in individuals with delirium and dementia ( n = 58 ) , no relationship between dementia and these markers was found . For example , higher Braak stage was associated with dementia when no history of delirium ( odds ratio 2.0 , 95 % confidence interval 1.1–3.5 , P = 0.02 ) , but in those with a history of delirium , there was no significant relationship ( odds ratio 1.2 , 95 % confidence interval 0.2–6.7 , P = 0.85 ) . This trend for odds ratios to be closer to unity in the delirium and dementia group was observed for neuritic amyloid , apolipoprotein ε status , presence of infa rcts , α-synucleinopathy and neuronal loss in substantia nigra . These findings are the first to demonstrate in a true population study that delirium is a strong risk factor for incident dementia and cognitive decline in the oldest-old . However , in this study , the relationship did not appear to be mediated by classical neuropathologies associated with dementia Background The inflammatory cell product neopterin is elevated in serum before and during delirium . This suggests a role for disordered cell-mediated immunity or oxidative stress . Cerebrospinal fluid ( CSF ) neopterin levels reflect brain neopterin levels more closely than serum levels . Here we hypothesized that CSF neopterin levels would be higher in delirium . Methods In this prospect i ve cohort study , 139 elderly patients with acute hip fracture were recruited in Oslo and Edinburgh . Delirium was diagnosed with the confusion assessment method performed daily pre-operatively and on the first 5 days post-operatively . Paired CSF and blood sample s were collected at the onset of spinal anaesthesia . Neopterin levels were measured using high-performance liquid chromatography . Results Sixty-four ( 46 % ) of 139 hip fracture patients developed delirium perioperatively . CSF neopterin levels were higher in delirium compared to controls ( median 29.6 vs 24.7 nmol/mL , p = 0.003 ) , with highest levels in patients who developed delirium post-operatively . Serum neopterin levels were also higher in delirium ( median 37.0 vs 27.1 nmol/mL , p = 0.003 ) . CSF neopterin remained significantly associated with delirium after controlling for relevant risk factors . Higher neopterin levels were associated with poorer outcomes ( death or new institutionalization ) 1 year after surgery ( p = 0.02 for CSF and p = 0.03 for serum ) . Conclusions This study is the first to examine neopterin in CSF from patients with delirium . Our findings suggest potential roles for activation of cell-mediated immune responses or oxidative stress in the delirium process . High levels of serum or CSF neopterin in hip fracture patients may also be useful in predicting poor outcomes Background To examine whether delirium in hip fracture patients was associated with changes in the levels of amino acids and /or monoamine metabolites in cerebrospinal fluid ( CSF ) and serum . Methods In this prospect i ve cohort study , 77 patients admitted with an acute hip fracture to Oslo University Hospital , Norway , were studied . The concentrations of amino acids in CSF and serum were determined by high performance liquid chromatography . The patients were assessed daily for delirium by the Confusion Assessment Method ( pre-operatively and post-operative day 1–5 ( all ) or until discharge ( delirious patients ) ) . Pre-fracture dementia status was decided by an expert panel . Serum was collected pre-operatively and CSF immediately before spinal anesthesia . Results Fifty-three ( 71 % ) hip fracture patients developed delirium . In hip fracture patients without dementia ( n = 39 ) , those with delirium had significantly higher CSF levels of tryptophan ( 40 % higher ) , tyrosine ( 60 % higher ) , phenylalanine ( 59 % higher ) and the monoamine metabolite 5-hydroxyindoleacetate ( 23 % higher ) compared to those without delirium . The same amino acids were also higher in CSF in delirious patients with dementia ( n = 38 ) . The correlations between serum and CSF amino acid levels were poor . Conclusion Higher CSF levels of monoamine precursors in hip fracture patients with delirium suggest a higher monoaminergic activity in the central nervous system during delirium in this patient group BACKGROUND Delirium is a risk factor for dementia in cognitively intact patients . Whether an episode of delirium accelerates cognitive decline in patients with known dementia , is less explored . METHODS This is a prospect i ve follow-up study of 287 hip fracture patients with pre-fracture cognitive impairment . During the hospitalization , the patients were screened daily for delirium using the Confusion Assessment Method . Pre-fracture cognitive impairment was defined as a score of 3.44 or higher on the pre-fracture Informant Question naire on Cognitive Decline in the Elderly Short Form ( IQCODE-SF ) . At follow-up after 4 - 6 months , the caregivers rated cognitive changes emerging after the fracture using the IQCODE-SF , and the patients were tested with the Mini Mental State Examination ( MMSE ) . A sub-group of the patients had a pre-fracture MMSE score which was used to calculate the yearly decline on the MMSE in patients with and without delirium . RESULTS 201 of the 287 patients developed delirium in the acute phase . In linear regression analysis , delirium was a significant and independent predictor of a more prominent cognitive decline at follow-up measured by the IQCODE-SF question naire ( p=0.002 ) . Among patients having a pre-fracture MMSE score , the patients developing delirium had a median ( IQR ) yearly decline of 2.4 points ( 1.1 - 3.9 ) , compared to 1.0 points ( 0 - 1.9 ) in the group without delirium ( p=0.001 , Mann-Whitney test ) . CONCLUSIONS Hip fracture patients with pre-fracture dementia run a higher risk of developing delirium . Delirium superimposed on dementia is a significant predictor of an accelerated further cognitive decline Importance Delirium is associated with accelerated cognitive decline . The pathologic substrates of this association are not yet known , that is , whether they are the same as those associated with dementia , are independent , or are interrelated . Objective To examine whether the accelerated cognitive decline observed after delirium is independent of the pathologic processes of classic dementia . Design , Setting , and Participants Harmonized data from 987 individual brain donors from 3 observational cohort studies with population -based sampling ( Vantaa 85 + , Cambridge City Over-75s Cohort , Cognitive Function and Ageing Study ) performed from January 1 , 1985 , through December 31 , 2011 , with a median follow-up of 5.2 years until death , were used in this study . Neuropathologic assessment s were performed with investigators masked to clinical data . Data analysis was performed from January 1 , 2012 , through December 31 , 2013 . Clinical characteristics of brain donors were not different from the rest of the cohort . Outcome ascertainment was complete given that the participants were brain donors . Exposures Delirium ( never vs ever ) and pathologic burden of neurofibrillary tangles , amyloid plaques , vascular lesions , and Lewy bodies . Effects modeled using r and om-effects linear regression and interactions between delirium and pathologic burden were assessed . Outcomes Change in Mini-Mental State Examination ( MMSE ) scores during the 6 years before death . Results There were 987 participants ( 290 from Vantaa 85 + , 241 from the Cambridge City Over-75s Cohort , and 456 from the Cognitive Function and Ageing Study ) with neuropathologic data ; mean ( SD ) age at death was 90 ( 6.4 ) years , including 682 women ( 69 % ) . The mean MMSE score 6 years before death was 24.7 points . The 279 individuals with delirium ( 75 % women ) had worse initial scores ( −2.8 points ; 95 % CI , −4.5 to −1.0 ; P < .001 ) . Cognitive decline attributable to delirium was −0.37 MMSE points per year ( 95 % CI , −0.60 to −0.13 ; P < .001 ) . Decline attributable to the pathologic processes of dementia was −0.39 MMSE points per year ( 95 % CI , −0.57 to −0.22 ; P < .001 ) . However , the combination of delirium and the pathologic processes of dementia result ed in the greatest decline , in which the interaction contributed an additional −0.16 MMSE points per year ( 95 % CI , −0.29 to −0.03 ; P = .01 ) . The multiplicative nature of these variables result ed in individuals with delirium and the pathologic processes of dementia declining 0.72 MMSE points per year faster than age- , sex- , and educational level – matched controls . Conclusions and Relevance Delirium in the presence of the pathologic processes of dementia is associated with accelerated cognitive decline beyond that expected for delirium or the pathologic process itself . These findings suggest that additional unmeasured pathologic processes specifically relate to delirium . Age-related cognitive decline has many contributors , and these findings at the population level support a role for delirium acting independently and multiplicatively to the pathologic processes of classic dementia OBJECTIVES To examine whether anticholinergic activity ( AA ) in cerebrospinal fluid ( CSF ) and serum is associated with risk of delirium in individuals with hip fracture . DESIGN Prospect i ve cohort study . SETTING Two university hospitals in Oslo , Norway , and Edinburgh , UK . PARTICIPANTS Individuals admitted with acute hip fracture ( N = 151 ) . MEASUREMENTS Participants were assessed daily for delirium using the Confusion Assessment Method ( preoperatively and postoperative days 1 - 5 ( all ) or until discharge ( participants with delirium ) ) . Prefracture cognitive function was assessed using the Informant Question naire on Cognitive Decline in the Elderly ( IQCODE ) . Serum was collected preoperatively and CSF at the onset of spinal anesthesia . AA in serum ( SAA ) and CSF sample s was determined according to a muscarinic radio receptor bioassay . The association between AA measures and delirium was evaluated using logistic multivariate analyses . RESULTS Fifty-two ( 54 % ) of the participants in Oslo and 20 ( 39 % ) in Edinburgh developed delirium . There was no statistically significant difference in AA between participants with and without delirium in Oslo ( serum : 7.02 vs 6.08 pmol/mL , P = .54 ; CSF : 0.39 vs 0.48 pmol/mL , P = .26 ) or in Edinburgh ( serum : 1.35 vs 1.62 pmol/mL , P = .76 ; CSF : 0.36 vs 0.31 pmol/mL , P = .93 ) . Nor was there any difference in SAA ( Oslo , P = .74 ; Edinburgh , P = .51 ) or CSF AA ( Oslo , P = .21 ; Edinburgh , P = .93 ) when participants were subdivided into prevalent , incident , subsyndromal , and never Output:	Nevertheless , the overall interpretation of the literature supports the vulnerable brain concept , that is , that biomarker evidence of , for example , Alzheimer 's disease pathology and /or neuroinflammation , is associated with delirium
MS2674	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The microcirculation appears to be impaired in cold chronic complex regional pain syndrome ( CRPS ) . This double-blind , placebo-controlled , r and omized trial investigated the effect of the nitric oxide ( NO ) donor isosorbide dinitrate ( ISDN ) on the peripheral blood flow in patients with chronic CRPS . Twenty-four patients received 1 % ISDN in Vaseline or a placebo ointment applied to the dorsum of the affected h and four times daily for 10 weeks . The patients participated in a physical therapy program to improve activity . The primary outcome measure was blood distribution in the affected extremity , which was determined by measuring the skin temperature using videothermography . We also measured NO and endothelin-1 concentrations in blister fluid , pain using the visual analog scale , and activity limitations using an upper limb activity monitor and the Disabilities of Arm Shoulder and H and Question naire . ISDN failed to produce a significant improvement in temperature asymmetry in chronic cold CRPS patients , and it did not result in the expected reduction in pain and increase in activity compared with placebo either . There may be other central or peripheral factors contributing to the disturbed vasodynamics in cold chronic CRPS that are not influenced by NO substitution . This study does not show an improvement of the regional blood distribution by ISDN in the involved extremity of patients with cold-type CRPS Abstract Animal and human studies indicate that electrical stimulation of dorsal root ganglion ( DRG ) neurons may modulate neuropathic pain signals . ACCURATE , a pivotal , prospect i ve , multicenter , r and omized comparative effectiveness trial , was conducted in 152 subjects diagnosed with complex regional pain syndrome or causalgia in the lower extremities . Subjects received neurostimulation of the DRG or dorsal column ( spinal cord stimulation , SCS ) . The primary end point was a composite of safety and efficacy at 3 months , and subjects were assessed through 12 months for long-term outcomes and adverse events . The predefined primary composite end point of treatment success was met for subjects with a permanent implant who reported 50 % or greater decrease in visual analog scale score from preimplant baseline and who did not report any stimulation-related neurological deficits . No subjects reported stimulation-related neurological deficits . The percentage of subjects receiving ≥50 % pain relief and treatment success was greater in the DRG arm ( 81.2 % ) than in the SCS arm ( 55.7 % , P < 0.001 ) at 3 months . Device-related and serious adverse events were not different between the 2 groups . Dorsal root ganglion stimulation also demonstrated greater improvements in quality of life and psychological disposition . Finally , subjects using DRG stimulation reported less postural variation in paresthesia ( P < 0.001 ) and reduced extraneous stimulation in nonpainful areas ( P = 0.014 ) , indicating DRG stimulation provided more targeted therapy to painful parts of the lower extremities . As the largest prospect i ve , r and omized comparative effectiveness trial to date , the results show that DRG stimulation provided a higher rate of treatment success with less postural variation in paresthesia intensity compared to SCS OBJECTIVES Complex regional pain syndrome ( CRPS ) , formerly known as reflex sympathetic dystrophy ( RSD ) , is a painful , disabling disorder for which treatment is difficult . The aim of this study was to determine the efficacy of pamidronate in a double-blind r and omized placebo-controlled trial . METHODS Patients referred to our regional multidisciplinary pain management center who fulfilled the International Association for the Study of Pain criteria for CRPS Type I were enrolled in the study over a 2-year period . Patients were administered , intravenously , either pamidronate , 60 mg as a single dose , or normal saline . Patients ' pain scores , global assessment of disease severity scores , and functional assessment ( SF-36 ) scores were documented at baseline and at 1 and 3 months . RESULTS Twenty-seven patients ( 18 female , 9 male ; average age 45 years ) were recruited , of whom 14 received pamidronate and 13 received placebo . Overall improvements in pain score , patient 's global assessment of disease severity score , and physical function ( SF-36 ) score were noted in the pamidronate group at 3 months , and improvements in role physical ( SF-36 ) score were noted at 1 and 3 months . There was variability in pamidronate response among individuals . CONCLUSIONS Pamidronate may be a useful treatment option in the management of patients with CRPS Type I. Although treatment response was variable , the majority of patients improved . Early administration in t and em with other treatment measures is recommended Chronic reflex sympathetic dystrophy is a painful , disabling disorder for which no treatment with proven effect is available . We performed a r and omized trial in a 2 to 1 ratio of patients , in which 36 patients were treated with spinal cord stimulation and physical therapy ( SCS+PT ) , and 18 patients received solely PT . Twenty‐four SCS+PT patients were given a permanent spinal cord stimulation system after successful test stimulation ; the remaining 12 patients received no permanent system . We assessed pain intensity , global perceived effect , functional status , and health‐related quality of life . Patients were examined before r and omization , before implantation , and also at 1 , 3 , 6 , 12 , and 24 months thereafter . At 2 years , three patients were excluded from the analysis . The intention‐to‐treat analysis showed improvements in the SCS+PT group concerning pain intensity ( −2.1 vs 0.0 cm ; p < 0.001 ) and global perceived effect ( 43 % vs 6 % “ much improved ” ; p = 0.001 ) . There was no clinical ly important improvement of functional status . Health‐related quality of life improved only in the group receiving spinal cord stimulation . After careful selection and successful test stimulation , spinal cord stimulation results in a long‐term pain reduction and health‐related quality of life improvement in chronic reflex sympathetic dystrophy & NA ; Complex regional pain syndrome type 1 ( CRPS1 ) involves cortical abnormalities similar to those observed in phantom pain and after stroke . In those groups , treatment is aim ed at activation of cortical networks that subserve the affected limb , for example mirror therapy . However , mirror therapy is not effective for chronic CRPS1 , possibly because movement of the limb evokes intolerable pain . It was hypothesised that preceding mirror therapy with activation of cortical networks without limb movement would reduce pain and swelling in patients with chronic CRPS1 . Thirteen chronic CRPS1 patients were r and omly allocated to a motor imagery program ( MIP ) or to ongoing management . The MIP consisted of two weeks each of a h and laterality recognition task , imagined h and movements and mirror therapy . After 12 weeks , the control group was crossed‐over to MIP . There was a main effect of treatment group ( F(1,11)=57 , P<0.01 ) and an effect size of ∼25 points on the Neuropathic pain scale . The number needed to treat for a 50 % reduction in NPS score was ∼2 . The effect of treatment was replicated in the crossed‐over control subjects . The results uphold the hypothesis that a MIP initially not involving limb movement is effective for CRPS1 and support the involvement of cortical abnormalities in the development of this disorder . Although the mechanisms of effect of the MIP are not clear , possible explanations are sequential activation of cortical pre‐motor and motor networks , or sustained and focussed attention on the affected limb , or both OBJECTIVES To explore the feasibility of intravenous magnesium administration as a potential c and i date intervention for a large size trial in Complex Regional Pain Syndrome Type 1 ( CRPS 1 ) . DESIGN R and omized clinical trial . SETTING Outpatient pain clinic . PATIENTS Ten CRPS 1 patients . INTERVENTIONS Eight patients received 70 mg/kg magnesium sulphate infusions in 4 hours for 5 days . For blinding purpose s , 2 patients received equal amount NaCl 0.9 % solutions ( data not analyzed or presented ) . Interventions were accompanied by st and ardized physical therapy . OUTCOME MEASURES Pain was assessed using an 11-point Box scale ( three times daily for a week ) and the McGill Pain Question naire . Skin sensitivity was measured with the Semmes Weinstein Monofilaments , ( other ) impairments with the Impairment Level Sumscore . In addition , functional limitations ( Radboud Skills Question naire , question naire rising and sitting down ) and quality of life ( Short Form-36 [ SF-36 ] , EuroQol ) were evaluated . Assessment s were performed at baseline , 1 , 3 , 6 , and 12 weeks after intervention . RESULTS Mild systemic side effects were experienced and the infusions were locally well tolerated . Pain was significantly reduced at all follow up compared with baseline ( T1 : P = 0.01 , T3 : P = 0.04 , T6 : P = 0.02 , T12 : P = 0.02 ) . McGill sensory subscale improved significantly at T1 ( number of words chosen : P = 0.03 and pain rating index : P = 0.03 ) . Impairment level ( P = 0.03 ) and quality of life ( EuroQol P = 0.04 , SF-36 physical P = 0.01 ) were significantly improved at T12 . No improvement was found for skin sensitivity and functional limitations . CONCLUSION Intravenous magnesium significantly improved pain , impairment and quality of life and was well tolerated . The results of this pilot study are encouraging and suggest that magnesium IV as a treatment in CRPS 1 should be further explored in a large size formal trial design & NA ; In complex regional pain syndrome ( CRPS1 ) initiated by wrist fracture , a motor imagery program ( MIP ) , consisting of h and laterality recognition followed by imagined movements and then mirror movements , reduces pain and disability , but the mechanism of effect is unclear . Possibilities include sustained attention to the affected limb , in which case the order of MIP components would not alter the effect , and sequential activation of cortical motor networks , in which case it would . Twenty subjects with chronic CRPS1 initiated by wrist fracture and who satisfied stringent inclusion criteria , were r and omly allocated to one of three groups : h and laterality recognition , imagined movements , mirror movements ( RecImMir , MIP ) ; imagined movements , recognition , imagined movements ( ImRecIm ) ; recognition , mirror movements , recognition ( RecMirRec ) . At 6 and 18 weeks , reduced pain and disability were greater for the RecImMir group than for the other groups ( P<0.05 ) . H and laterality recognition imparted a consistent reduction in pain and disability across groups , however , this effect was limited in magnitude . Imagined movements imparted a further reduction in pain and disability , but only if they followed h and laterality recognition . Mirror movements also imparted a reduction in pain and disability , but only when they followed imagined movements . The effect of the MIP seems to be dependent on the order of components , which suggests that it is not due to sustained attention to the affected limb , but is consistent with sequential activation of cortical motor networks Background . Complex regional pain syndrome type 1 ( CRPSt1 ) of the upper limb is a painful and debilitating condition , frequent after stroke , and interferes with the rehabilitative process and outcome . However , treatments used for CRPSt1 of the upper limb are limited . Objective . This r and omized controlled study was conducted to compare the effectiveness on pain and upper limb function of mirror therapy on CRPSt1 of upper limb in patients with acute stroke . Methods . Of 208 patients with first episode of unilateral stroke admitted to the authors ’ rehabilitation center , 48 patients with CRPSt1 of the affected upper limb were enrolled in a r and omized controlled study , with a 6-month follow-up , and assigned to either a mirror therapy group or placebo control group . The primary end points were a reduction in the visual analogue scale score of pain at rest , on movement , and brush-induced tactile allodynia . The secondary end points were improvement in motor function as assessed by the Wolf Motor Function Test and Motor Activity Log . Results . The mean scores of both the primary and secondary end points significantly improved in the mirror group ( P < .001 ) . No statistically significant improvement was observed in any of the control group values ( P > .001 ) . Moreover , statistically significant differences after treatment ( P < .001 ) and at the 6-month follow-up were found between the 2 groups . Conclusions . The results indicate that mirror therapy effectively reduces pain and enhances upper limb motor function in stroke patients with upper limb CRPSt1 Objective To compare the effectiveness of pain exposure physical therapy ( PEPT ) with conventional treatment in patients with complex regional pain syndrome type 1 ( CRPS-1 ) in a r and omised controlled trial with a blinded assessor . Setting The study was conducted at a level 1 trauma centre in the Netherl and s. Participants 56 adult patients with CRPS-1 participated . Three patients were lost to follow-up . Interventions Patients received either PEPT in a maximum of five treatment sessions , or conventional treatment following the Dutch multidisciplinary guideline . Measurements Outcomes were assessed at baseline and at 3 , 6 and 9 months after r and omisation . The primary outcome measure was the Impairment level Sum Score — Restricted Version ( ISS-RV ) , consisting of visual analogue scale for pain ( VAS-pain ) , McGill Pain Question naire , active range of motion ( AROM ) and skin temperature . Secondary outcome measures included Pain Disability Index ( PDI ) ; muscle strength ; Short Form 36 ( SF-36 ) ; disability of arm , shoulder and h and ; Lower Limb Tasks Question naire ( LLTQ ) ; 10 m walk test ; timed up- and -go test ( TUG ) and EuroQol-5D . Results The intention-to-treat analysis showed a clinical ly relevant decrease in ISS-RV ( 6.7 points for PEPT and 6.2 points for conventional treatment ) , but the between-group difference was not significant ( 0.96 Output:	Published trials continue to support the use of bisphosphonates and short courses of oral steroids in the setting of CRPS . Similarly , trials also suggest an exp and ing role for peripheral sympathetic blockade ( i.e. , lumbar/thoracic sympathetic , stellate ganglion , and brachial plexus blocks ) . Les essais suggèrent également un plus gr and rôle pour le bloc sympathique périphérique ( c’est-à-dire , blocs sympathiques lombaires/thoraciques , bloc du ganglion cervico-thoracique et du plexus brachial ) .
MS2675	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Individuals with type 2 diabetes have increased fracture risk despite higher bone mineral density ( BMD ) . Our aim was to examine the influence of glucose control on skeletal complications . RESEARCH DESIGN AND METHODS Data of 4,135 participants of the Rotterdam Study , a prospect i ve population -based cohort , were available ( mean follow-up 12.2 years ) . At baseline , 420 participants with type 2 diabetes were classified by glucose control ( according to HbA1c calculated from fructosamine ) , result ing in three comparison groups : adequately controlled diabetes ( ACD ; n = 203 ; HbA1c < 7.5 % ) , inadequately controlled diabetes ( ICD ; n = 217 ; HbA1c ≥7.5 % ) , and no diabetes ( n = 3,715 ) . Models adjusted for sex , age , height , and weight ( and femoral neck BMD ) were used to test for differences in bone parameters and fracture risk ( hazard ratio [ HR ] [ 95 % CI ] ) . RESULTS The ICD group had 1.1–5.6 % higher BMD , 4.6–5.6 % thicker cortices , and −1.2 to −1.8 % narrower femoral necks than ACD and ND , respectively . Participants with ICD had 47–62 % higher fracture risk than individuals without diabetes ( HR 1.47 [ 1.12–1.92 ] ) and ACD ( 1.62 [ 1.09–2.40 ] ) , whereas those with ACD had a risk similar to those without diabetes ( 0.91 [ 0.67–1.23 ] ) . CONCLUSIONS Poor glycemic control in type 2 diabetes is associated with fracture risk , high BMD , and thicker femoral cortices in narrower bones . We postulate that fragility in apparently “ strong ” bones in ICD can result from microcrack accumulation and /or cortical porosity , reflecting impaired bone repair The determine the effect of different foods on the blood glucose , 62 commonly eaten foods and sugars were fed individually to groups of 5 to 10 healthy fasting volunteers . Blood glucose levels were measured over 2 h , and expressed as a percentage of the area under the glucose response curve when the same amount of carbohydrate was taken as glucose . The largest rises were seen with vegetables ( 70 + /- 5 % ) , followed by breakfast cereals ( 65 + /- 5 % ) , cereals and biscuits ( 60 + /- 3 % ) , fruit ( 50 + /- 5 % ) , dairy products ( 35 + /- 1 % ) , and dried legumes ( 31 + /- 3 % ) . A significant negative relationship was seen between fat ( p less than 0.01 ) and protein ( p less than 0.001 ) and postpr and ial glucose rise but not with fiber or sugar content The aim of the present study was to assess reproducibility and relative validity of a self-administered FFQ used in the PREDIMED Study , a clinical trial for primary prevention of CVD by Mediterranean diet in a population at high cardiovascular risk . The FFQ was administered twice ( FFQ1 and FFQ2 ) to explore reproducibility at 1 year . Four 3 d dietary records ( DR ) were used as reference to explore validity ; participants therefore recorded their food intake over 12 d in the course of 1 year . The degree of misclassification in the FFQ was also evaluated by a contingency table of quintiles comparing the information from the FFQ2 and the DR . A total of 158 men and women ( aged 55 - 80 years ) were asked not to modify their dietary habits during the study period . Reproducibility for food groups , energy and nutrient intake , explored by the Pearson correlation coefficient ( r ) ranged 0.50 - 0.82 , and the intraclass correlation coefficient ( ICC ) ranged from 0.63 to 0.90 . The FFQ2 tended to report higher energy and nutrient intake than the DR . The validity indices of the FFQ in relation to the DR for food groups and energy and nutrient intake ranged ( r ) from 0.24 to 0.72 , while the range of the ICC was between 0.40 and 0.84 . With regard to food groups , 68 - 83 % of individuals were in the same or adjacent quintile in both methods , a figure which decreased to 55 - 75 % for energy and nutrient intake . We concluded that FFQ measurements had good reproducibility and a relative validity similar to those of FFQ used in other prospect i ve studies Hip fractures are the most devastating consequence of osteoporosis and impact 1 in 6 white women leading to a two- to threefold increased mortality risk in the first year . Despite evidence of inflammatory markers in the pathogenesis of osteoporosis , few studies have examined their effect on hip fracture . To determine if high levels of inflammation increase hip fracture risk and to explore mediation pathways , a case-cohort design nested in a cohort of 4709 white women from the Study of Osteoporotic Fractures was used . A r and om sample of 1171 women was selected as the subcohort ( mean age 80.1 ± 4.2 years ) plus the first 300 women with incident hip fracture . Inflammatory markers interleukin-6 ( IL-6 ) and soluble receptors ( SR ) for IL-6 ( IL-6 SR ) and tumor necrosis factor ( TNF SR1 and TNF SR2 ) were measured , and participants were followed for a median ( interquartile range ) of 6.3 ( 3.7 , 6.9 ) years . In multivariable models , the hazard ratio ( HR ) of hip fracture for women in the highest inflammatory marker level ( quartile 4 ) was 1.64 ( 95 % confidence interval [ CI ] , 1.09 - 2.48 , p trend = 0.03 ) for IL-6 and 2.05 ( 95 % CI , 1.35 - 3.12 , p trend < 0.01 ) for TNF SR1 when compared with women in the lowest level ( quartile 1 ) . Among women with 2 and 3 - 4 inflammatory markers in the highest quartile , the HR of hip fracture was 1.51 ( 95 % CI , 1.07 - 2.14 ) and 1.42 ( 95 % CI , 0.87 - 2.31 ) compared with women with zero to one marker(s ) in the highest quartile ( p trend = 0.03 ) . After individually adjusting for seven potential mediators , cystatin-C ( a biomarker of renal function ) and bone mineral density ( BMD ) attenuated HRs among women with the highest inflammatory burden by 64 % and 50 % , respectively , suggesting a potential mediating role . Older white women with high inflammatory burden are at increased risk of hip fracture in part due to poor renal function and low BMD CONTEXT AND OBJECTIVE Because it has been suggested that osteocalcin ( OC ) , an osteoblast-derived hormone , is a new link between bone and glucose metabolism , we tested whether serum carboxylated osteocalcin ( cOC ) and undercarboxylated osteocalcin ( ucOC ) levels are independently associated with the development of type 2 diabetes in subjects at high cardiovascular risk . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve , nested case-control study was conducted using data from the Prevención con Dieta Mediterránea ( PREDIMED ) study . We included 153 case subjects with newly diagnosed diabetes and 306 individually matched control subjects free of diabetes identified during a mean 5-year follow-up . Conditional logistic regression models were used to estimate matched odds ratios for incident diabetes according to categories of both forms of OC measured by ELISAs . RESULTS Baseline serum concentrations of both forms of OC were significantly lower in case subjects than in control subjects . In subjects with incident cases of diabetes , concentrations of cOC , but not of ucOC , were inversely and significantly associated with homeostasis model assessment of insulin resistance levels ( β = -0.335 ) and with fasting glucose concentrations ( β = -0.044 ) in control subjects , independent of other relevant confounders . In the conditional logistic model that took into account the matching factors , the odds ratios for diabetes incidence in the lowest vs the highest tertile of cOC and ucOC were 2.03 ( 95 % confidence interval , 1.32 - 3.13 ) and 1.88 ( 1.23 - 2.85 ) , respectively . Further adjustment for family history of diabetes , lifestyle , and other confounding factors did not appreciably change the magnitude of these associations . CONCLUSION In a population at high cardiovascular risk , low concentrations of serum cOC and ucOC were strongly associated with an increased risk of incident diabetes OBJECTIVE To examine prospect ively the relationship between glycemic diets , low fiber intake , and risk of non-insulin-dependent diabetes mellitus . DESIGN Cohort study . SETTING In 1986 , a total of 65173 US women 40 to 65 years of age and free from diagnosed cardiovascular disease , cancer , and diabetes completed a detailed dietary question naire from which we calculated usual intake of total and specific sources of dietary fiber , dietary glycemic index , and glycemic load . MAIN OUTCOME MEASURE Non-insulin-dependent diabetes mellitus . RESULTS During 6 years of follow-up , 915 incident cases of diabetes were documented . The dietary glycemic index was positively associated with risk of diabetes after adjustment for age , body mass index , smoking , physical activity , family history of diabetes , alcohol and cereal fiber intake , and total energy intake . Comparing the highest with the lowest quintile , the relative risk ( RR ) of diabetes was 1.37 ( 95 % confidence interval [ CI ] , 1.09 - 1.71 , P trend=.005 ) . The glycemic load ( an indicator of a global dietary insulin dem and ) was also positively associated with diabetes ( RR= 1.47 ; 95 % CI , 1.16 - 1.86 , P trend=.003 ) . Cereal fiber intake was inversely associated with risk of diabetes when comparing the extreme quintiles ( RR=0.72 , 95 % CI , 0.58 - 0.90 , P trend=.001 ) . The combination of a high glycemic load and a low cereal fiber intake further increased the risk of diabetes ( RR=2.50 , 95 % CI , 1.14 - 5.51 ) when compared with a low glycemic load and high cereal fiber intake . CONCLUSIONS Our results support the hypothesis that diets with a high glycemic load and a low cereal fiber content increase risk of diabetes in women . Further , they suggest that grains should be consumed in a minimally refined form to reduce the incidence of diabetes BACKGROUND Osteocalcin has been related to insulin secretion in experimental models . Few prospect i ve studies have evaluated the association between circulating osteocalcin concentrations and insulin secretion and sensitivity in humans . OBJECTIVE The objective was to examine cross-sectional and longitudinal associations between circulating forms of osteocalcin and insulin secretion and sensitivity in elderly men at high cardiovascular risk . DESIGN We examined cross-sectional and longitudinal associations between serum measurements of total osteocalcin and undercarboxylated osteocalcin ( ucOC ) with fasting glucose , fasting insulin , HOMA-IR , and HOMA β cell function ( HOMA-BCF ) in 79 elderly men . We also examined the association between 2-y changes in osteocalcin and changes in fasting glucose , insulin , HOMA-IR , and HOMA-BCF . RESULTS In an adjusted multivariable linear regression analysis , increases in serum osteocalcin were significantly associated with an increase in HOMA-BCF ( β coefficient : 2.87 ; 95 % CI : 0.23 , 5.52 ; P = 0.033 ) , and changes in ucOC were linked to a decrease in HOMA-IR ( β coefficient : -0.31 ; 95 % CI : -0.60 , 0.03 ; P = 0.032 ) . Moreover , in subjects not taking oral antidiabetic drugs , baseline osteocalcin concentrations were positively associated with higher fasting insulin concentrations and HOMA-BCF even after adjustment for BMI , physical activity , intervention group , presence of type 2 diabetes mellitus , and baseline values of each dependent variable . CONCLUSIONS Changes in serum osteocalcin and ucOC are associated with an improvement in insulin secretion and sensitivity , which suggests a possible role of bone in the development of type 2 diabetes . This trial is registered at clinical trials.gov as IS RCT N35739639 The proinflammatory cytokines interleukin-1 beta ( IL-1 beta ) and IL-6 may play a central role in the acceleration of postmenopausal bone loss , but observational studies have led to contradictory results . Estrogen-dependent changes in the production Output:	Conclusions A high DGI and DGL are associated with a higher risk of osteoporosis-related fractures in an elderly Mediterranean population at high cardiovascular disease risk .
MS2676	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Conflict between clinical importance and statistical significance is an important problem in medical research . Although clinical importance is best described by asking for the effect size or how much , statistical significance can only suggest whether there is any difference . One way to combine statistical significance and effect sizes is to report confidence intervals . We therefore assessed the reporting of confidence intervals in the orthopaedic literature and factors influencing this frequency . In parallel , we tested the predictive value of statistical significance for effect size . In a r and om sample of predetermined size , we found one in five orthopaedic articles reported confidence intervals . Participation of an individual trained in research methods increased the odds of doing so fivefold . The use of confidence intervals was independent of impact factor , year of publication , and significance of outcomes . The probability of statistically significant results to predict at least a 10 % between-group difference was only 69 % ( 95 % confidence interval , 55%–83 % ) , suggesting that a high proportion of statistically significant results do not reflect large treatment effects . Confidence intervals could help avoid such erroneous interpretation by showing the effect size explicitly Delayed rather than early reconstruction of the anterior cruciate ligament is the current recommended treatment for injury to this ligament since it is thought to give a better functional outcome . We r and omised 105 consecutive patients with injury associated with chondral lesions no more severe than grade s 1 and 2 and /or meniscal tears which only required trimming , to early ( < two weeks ) or delayed ( > four to six weeks ) reconstruction of the anterior cruciate ligament using a quadrupled hamstring graft . All operations were performed by a single surgeon and a st and ard rehabilitation regime was followed in both groups . The outcomes were assessed using the Lysholm score , the Tegner score and measurement of the range of movement . Stability was assessed by clinical tests and measurements taken with the KT-1000 arthrometer , with all testing performed by a blinded uninvolved experienced observer . A total of six patients were lost to follow-up , with 48 patients assigned to the delayed group and 51 to the early group . None was a competitive athlete . The mean interval between injury and the surgery was seven days ( 2 to 14 ) in the early group and 32 days ( 29 to 42 ) in the delayed group . The mean follow-up was 32 months ( 26 to 36 ) . The results did not show a statistically significant difference for the Lysholm score ( p = 0.86 ) , Tegner activity score ( p = 0.913 ) or the range of movement ( p = 1 ) . Similarly , no distinction could be made for stability testing by clinical examination ( p = 0.56 ) and measurements with the KT-1000 arthrometer ( p = 0.93 ) . Reconstruction of the anterior cruciate ligament gave a similar clinical and functional outcome whether performed early ( < two weeks ) or late at four to six weeks after injury Introduction Correct placement of both tibial and femoral tunnels is one of the main factors for a favorable clinical outcome after anterior cruciate ligament ( ACL ) reconstruction . We used an original system of computer assisted surgery ( CAS ) . The system , based on fluoroscopic guidance combined with special graphical software of image analyzing , showed to the surgeon , before drilling , the recommended placement of tibial and femoral tunnel centers . We compared the first anatomical and clinical results of this procedure to the usual one single incision technique . Material s and methods We conducted a prospect i ve study on 73 patients ; 37 patients were operated on with CAS and 36 without CAS , by the same senior surgeon . The mean age was 27 years for both groups . Every patient was review ed at an average of 2.2 years ( range 1–4.5 ) by an independent observer , using IKDC scoring system , KT-1000 , and passive stress radiographs . Results Time between ACL rupture and reconstruction averaged 30 months for both groups . CAS needed 9.3 min extra surgery time . Clinical evaluation was grade d from A to C as per the IKDC scoring system : 67.6 % A , 29.7 % B , 2.7 % C with CAS ; and 60 % A , 37.1 % B , 2.9 % C without CAS . IKDC subjective knee evaluation score averaged 89.7 with CAS and 89.5 without CAS . Pre operative KT-1000 maxi manual differential laxity averaged 7 . At revision time , all the patients after CAS had a differential laxity less than 2 and 97.7 % without CAS . Stress X-rays differential laxity averaged 2.4 mm with CAS and 3 mm without CAS . The area of dispersion of the tunnels ’ center was smaller on the femoral side using the CAS method . There was no statistically significant difference between both groups using IKDC score , KT-1000 and passive stress radiographs . Conclusions The CAS method provided a more accurate and reproducible tunnels placement without clinical significant effect OBJECTIVES : To compare the accuracy of tunnel placement and graft isometry for anterior cruciate ligament reconstruction performed using a computer-assisted navigation system ( Orthopilot ) and using traditional instruments . METHODS : The anterior cruciate ligament was removed intact from 36 pairs of human cadaver knees . From each pair , one knee was r and omized to Group 1 ( conventional ) and the other to Group 2 ( Orthopilot ) . An inelastic suture was then passed through the central points of the tibial and femoral tunnels . Neither of the tunnels was drilled . All knees were then dissected , and six parameters were obtained : distances from the tibial tunnel center to the 1 ) posterior cruciate ligament , 2 ) anterior horn of the lateral meniscus and 3 ) medial tibial spine ; 4 ) distance from the femoral tunnel center to the posterior femoral cortex ; 5 ) femoral tunnel coronal angle ; and 6 ) variation of the distance from the femoral to the tibial tunnel with the knee extended and at 90 degrees of flexion . RESULTS : The variation of the distance from the femoral to the tibial tunnel during flexion and extension was smaller in the Orthopilot group ( better isometry ) compared to the conventional group . There were no statistical differences in any other parameters between the groups , and all tunnels were considered to be in satisfactory positions . DISCUSSION : The results obtained for anterior cruciate ligament reconstruction depend on precise isometric point positioning , and a navigation system is a precision tool that can assist surgeons in tunnel positioning . CONCLUSION : No differences in tunnel position were observed between the groups . Nonetheless , better isometry was achieved in the Orthopilot group than with conventional instruments Evidence -based medicine integrates clinical expertise , patients ' values and preferences , and the best available evidence from the medical literature . Evidence -based orthopedics is a model to assist surgeons to improve the process of asking questions , obtaining relevant information efficiently , and making informed decisions with patients . With an increasing appreciation for higher levels of evidence , orthopedic surgeons should move away from lower forms of evidence . The adoption of r and omized trials and high- quality prospect i ve studies to guide patient care requires 2 prerequisites : ( 1 ) greater appreciation for the conduct of r and omized trials in orthopedics and ( 2 ) improved education and training in evidence -based method ologies in surgery To correlate clinical results after anterior cruciate liga ment reconstruction with tunnel placement measured radiographically , we prospect ively studied 128 patients who had arthroscopically assisted bone-patellar ten don-bone reconstructions . Patients with bilateral ante rior cruciate ligament reconstructions , other significant knee ligament injuries , or those undergoing chondro plasty or meniscal repairs were excluded , leaving 42 patients . The relationship between radiographic tunnel position and clinical results was determined using the Lysholm score , KT-1000 arthrometer testing , the Teg ner activity level , and the pivot shift and Lachman tests . Clinical results correlated positively with posterior fem oral tunnel placement on lateral radiographs and neg atively with excessive anterior tibial tunnel placement . Specifically , when femoral tunnels were placed at least 60 % posterior along Blumensaat 's line and tibial tun nels were at least 20 % posterior along the tibial pla teau , 69 % of patients had good or excellent Lysholm scores and 79 % had KT-1000 arthrometer maximum manual side-to-side differences of 3 mm or less . When the above criteria were not met , 50 % of patients had good or excellent Lysholm scores and 22 % had KT- 1000 arthrometer maximum manual side-to-side differ ences of 3 mm or less . This close correlation indicates that satisfactory radiographic tunnel position influences outcome after anterior cruciate ligament reconstruc tion PURPOSE The purpose of this study was to evaluate the benefits of computer navigation on tunnel placement during anterior cruciate ligament reconstruction . METHODS A prospect i ve , r and omized , controlled study comparing computer navigation with manual operation was performed between December 2003 and April 2004 . We assigned 20 patients to the computer navigation group and 20 patients to the manual navigation group . Surgery was performed by use of a patellar tendon autograft with press-fit fixation . A lateral radiograph of the knee at maximum extension was used to determine the exact position of the tibial tunnel at 4 days postoperatively . Outcomes were evaluated with International Knee Documentation Committee 2000 , Tegner , and Lysholm scoring . There was an additional magnetic resonance imaging ( MRI ) evaluation of tunnel placement and graft quality at the most recent follow-up , approximately 24 months after surgery . RESULTS The postoperative radiographs and 2-year postoperative MRI scans showed no differences between groups for tibial or femoral tunnel placement . In both groups the mean tibial tunnel placement was 46 % of the maximal diameter of the tibia . There were no significant differences between groups for objective and subjective outcomes scoring . Although some qualitative differences existed between groups with respect to MRI graft appearance at 2 years , this had no correlation with overall results . CONCLUSIONS No significant differences were found between computer-assisted and manually navigated anterior cruciate ligament reconstruction with regard to tunnel placement and clinical results at a mean of 2 years postoperatively . LEVEL OF EVIDENCE Level I , r and omized , single-blinded , controlled trial Background Poor outcome in anterior cruciate ligament reconstruction is often related to tunnel position . Hypothesis Improving accuracy of the tunnel position will lead to improved outcome . Study Design R and omized controlled trial ; Level of evidence , 1 . Methods Sixty patients were r and omized to either st and ard instrumentation or computer-assisted guides to position the tibial and femoral tunnels . The results were evaluated on clinical outcome based on International Knee Documentation Committee form ( laxity ) and radiologic assessment : radiologic Lachman ( Telos at 150 and 200 N ) and analysis of the tunnel positions . Results International Knee Documentation Committee laxity was level A in 22 knees in the conventional group ( mean , 1.5 mm at 200 N ) compared with 26 navigated knees ( mean laxity , 1.3 mm ; P= .49 ) . Laxity was less than 2 mm in 96.7 % of the navigated group and 83 % of the conventional group ( P= .292 ) . The variability of laxity in the navigated group was significantly less than in the conventional group , with the st and ard deviation of the navigated group being smaller than that in the conventional group ( P= .0003 at 150 N and .0005 at 200 N Telos ) . A significant difference ( P= .03 ) was found between the groups in the ATB value ( distance between the projection of the Blumensaat line on the tibial plateau and the anterior edge of the tibial tunnel ) , characterizing the sagittal position of the tibial tunnel ( negative ATB values imply graft impingement in extension ) . In the conventional group , mean ATB was –0.2 ( –5 to + 4 ) , whereas it was 0.4 ( 0 to 3 ) in the navigated patients . There were no negative ATB values in the navigated group . Conclusion This study confirms that the accuracy and consistency of tibial tunnel position can be improved by the use of computer-assisted navigation and that the clinical result in terms of laxity is more reliable Background Next to graft fixation , correct positioning of the tibial and femoral tunnel is a deciding factor for the clinical result of anterior cruciate ligament reconstruction surgery . Computer-assisted navigation has been proposed as a method to improve tunnel positioning . Purpose To examine the differences in tibial tunnel placement between cruciate ligament operations using manual and computer-assisted navigation . Study Design R and omized controlled trial ; Level of evidence , 1 . Methods Between December 2003 and April 2004 , 53 athletes underwent anterior cruciate ligament reconstruction surgery with arthroscopic press-fit technique . The first group ( group N ; 24 athletes ) were operated on with the aid of a navigation system ( OrthoPilot , Aesculap AG & Co. KG , Braun ) , and the second group ( group M ; 29 athletes ) were “ manually ” operated on . A lateral radiograph of the knee at maximum extension was used to determine the exact position of the tibial tunnel four days postoperatively . In the measurements , the anterior and posterior boundaries of the tibial tunnel , as well as the center of the tibial tunnel in relation to the maximum tibia anteroposterior diameter were evaluated ( indicated in percent ) . An analysis of the tibial tunnel position proportional to the slope of the intercondylar roof was done to determine intercondylar impingement ( method according to Howell ) . The centers of the tibial tunnels were compared with the “ optimal ” position noted in previous studies . The st and ard deviation was determined for both groups to determine the variance of placement . Results The anterior tibial tunnel border was 19.4 mm in group M ( 29.7 % ) and 21.2 mm in group N ( 32.2 % ) ( P=.18 ) . The center of Output:	No significant differences between computer-navigated and conventional groups were found in terms of knee stability and functional assessment during short-term follow-up .
MS2677	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 ( 30 % soluble insulin aspart and 70 % protaminated insulin aspart [ BIAsp 30 ] ) and biphasic insulin lispro 25 ( 25 % soluble insulin lispro and 75 % neutral protamine lispro [ Mix25 ] ) used in a BID injection regimen in patients with type 2 diabetes mellitus ( DM ) . Also assessed was patients ' preference for pen device -- the NovoMix 30 FlexPen /NovoLog Mix 70/30 FlexPen ( FlexPen ) versus the Humalog Mix25 Pen/Humalog Mix75/25 Pen ( Humalog Pen ) . METHODS Patients with type 2 DM receiving current insulin treatment were r and omized to a multinational , multicenter , open-label , 2-period , crossover comparison of BIAsp 30 and Mix25 . Efficacy ( by analyses of variance ) and safety profiles were assessed after 12 weeks of treatment . Patients ' preference for pen device was assessed by question naires . RESULTS A total of 137 patients were r and omized to treatment ; 4 were withdrawn during the 2-week run-in treatment with biphasic human insulin 30 . The mean ( SD ) characteristics of the remaining 133 patients ( 79 men , 54 women ) were as follows : age , 62.3 ( 9.2 ) years ; body mass index , 28.1 ( 3.9 ) kg/m(2 ) ; and glycosylated hemoglobin ( HbA(1c ) ) , 8.5 % ( 1.1 ) . Glycemic control was assessed by the measurement of HbA(1c ) after 12 weeks of treatment . Treatment with BIAsp 30 was noninferior to treatment with Mix25 ( upper limit of 90 % CI for estimated difference [ BIAsp 30 - Mix25 ] was < 0.4 % ) . Self-monitored blood glucose levels were comparable ( P = NS ) . Adverse-event profiles were similar between treatments , as was the incidence of hypoglycemic episodes ( 0.69 episode/mo with BIAsp 30 and 0.62 episode/mo with Mix25 , P = 0.292 ) . For all device features assessed , the FlexPen consistently received higher scores ( all P < 0.005 ) . A total of 9.0 % of patients experienced problems with the FlexPen , compared with 32.4 % with the Humalog Pen ( P < 0.001 ) . Furthermore , 74.6 % preferred to continue using the FlexPen , whereas 14.3 % preferred the Humalog Pen ( P < 0.001 ) . CONCLUSIONS In this study , glycemic control with BIAsp 30 and Mix25 was found to be comparable in these patients with type 2 DM . Safety profiles were similar for both regimens . Patients preferred and experienced fewer problems with the FlexPen than the Humalog Pen OBJECTIVE Insulin detemir is a soluble long-acting basal insulin analog design ed to overcome the limitations of conventional basal insulin formulations . Accordingly , insulin detemir has been compared with NPH insulin with respect to glycemic control ( HbA1c , prebreakfast glucose levels and variability , and hypoglycemia ) and timing of administration . RESEARCH DESIGN AND METHODS People with type 1 diabetes ( n = 408 ) were r and omized in an open-label , parallel-group trial of 16-week treatment duration using either insulin detemir or NPH insulin . Insulin detemir was administered twice daily using two different regimens , either before breakfast and at bedtime ( IDet(morn+bed ) ) or at a 12-h interval ( IDet(12h ) ) . NPH insulin was administered before breakfast and at bedtime . Mealtime insulin was given as the rapid-acting insulin analog insulin aspart . RESULTS With both insulin detemir groups , clinic fasting plasma glucose was lower than with NPH insulin ( IDet(12h ) vs. NPH , -1.5 mmol/l [ 95 % CI -2.51 to -0.48 ] , P = 0.004 ; IDet(morn+bed ) vs. NPH , -2.3 mmol/l ( -3.32 to -1.29 ) , P < 0.001 ) , as was self-measured prebreakfast plasma glucose ( P = 0.006 and P = 0.004 , respectively ) . The risk of minor hypoglycemia was lower in both insulin detemir groups ( 25 % , P = 0.046 ; 32 % , P = 0.002 ; respectively ) compared with NPH insulin in the last 12 weeks of treatment , this being mainly attributable to a 53 % reduction in nocturnal hypoglycemia in the IDet(morn+bed ) group ( P < 0.001 ) . Although HbA1c for each insulin detemir group was not different from the NPH group , HbA1c for the pooled insulin detemir groups was significantly lower than for the NPH group ( mean difference -0.18 % [ -0.34 to -0.02 ] , P = 0.027 ) . Within-person between-day variation in self-measured prebreakfast plasma glucose was lower for both detemir groups ( both P < 0.001 ) . The NPH group gained weight during the study , but there was no change in weight in either of the insulin detemir groups ( IDet(12h ) vs. NPH , -0.8 kg [ -1.44 to -0.24 ] , P = 0.006 ; IDet(morn+bed ) vs. NPH , -0.6 kg [ -1.23 to -0.03 ] , P = 0.040 ) . CONCLUSIONS Overall glycemic control with insulin detemir was improved compared with NPH insulin . The data provide a basis for tailoring the timing of administration of insulin detemir to the individual person 's needs BACKGROUND AND AIM While lispro insulin has been reported to lower postpr and ial blood glucose concentrations , less consistent effects have been shown for glycosylated hemoglobin ( HbA1c ) levels . Aim of this study was to determine whether pre-meal association of NPH , an intermediate-acting insulin , with lispro improves overall glycemic control in type 1 diabetic patients . METHODS AND RESULTS Eighty-five type 1 diabetic patients were studied in a multicenter r and omized comparative ( human regular vs lispro insulin ) crossover ( 3-month ) study in which NPH insulin was given as a dinner or bedtime injection and at breakfast and lunch if necessary . The number of injections was kept constant : 42 % and 58 % of patients injected insulin 3 and 4 times per day , respectively . Fasting and prepr and ial blood glucose levels were similar , while postpr and ial levels improved after lispro compared to human regular insulin ( breakfast : 8.28 + /- 2.39 vs 9.28 + /- 2.72 mmol/l ; lunch : 8.33 + /- 2.67 vs 9.06 + /- 2.67 mmol/l , dinner : 8.06 + /- 2.72 vs 9.28 + /- 2.44 mmol/l , ANOVA : p = 0.003 ) . HbA1c also improved after lispro : 8.1 + /- 0.9 vs 8.3 + /- 0.8 % , p < 0.05 . The rate of hypoglycemia was similar . Patients showed better acceptance of lispro treatment ( p < 0.001 ) . CONCLUSIONS Lispro improves overall blood glucose control in type 1 diabetic patients without increasing the incidence of hypoglycemia . This can be achieved by an optimal combination of lispro insulin with NPH whenever the time intervals between meals are too long OBJECTIVE This study investigated the effect of insulin glargine ( LANTUS ) versus NPH insulin on metabolic control and safety in Asian patients with Type 2 diabetes , inadequately controlled on oral hypoglycemic agents ( OHAs ) . STUDY DESIGN AND METHODS In this open-label , r and omized , parallel , multinational , 24-week , non-inferiority study , 443 patients received either once-daily insulin glargine ( n=220 ) or NPH insulin ( n=223 ) at bedtime , plus glimepiride ( Amaryl ) . RESULTS Baseline characteristics were similar between the two groups . HbA(1c ) levels decreased in the insulin glargine and NPH groups over the study period in the per- protocol ( PP ; -1.10 % versus 0.92 % ) and full- analysis ( FA ; -0.99 % versus -0.77 % ) population s. In the PP population , the difference between adjusted means ( predefined equivalence region > -0.4 % ) was 0.19 % ( 90 % confidence interval [ CI ] : 0.02 , 0.36 ) , demonstrating non-inferiority between the two treatments . In a superiority analysis ( FA population ) , the difference between adjusted mean changes in the two groups was 0.22 % ( 95 % CI : 0.02 , 0.42 ) , demonstrating the superiority of insulin glargine ( p=0.0319 ) . Moreover , the number of hypoglycemic episodes was significantly lower with insulin glargine versus NPH insulin ( p<0.004 ) , particularly severe ( p<0.03 ) and nocturnal ( p<0.001 ) . Daily insulin dose increased from 9.6+/-1.5 to 32.1+/-17.6 U in the insulin glargine group and from 9.8+/-1.9 to 32.8+/-18.9 U in the NPH insulin group . CONCLUSION These results confirm earlier reports that insulin glargine provides superior glycemic control with less hypoglycemia and demonstrates that these benefits are consistent between different ethnicities Aims /hypothesisThe aim of the trial was to compare the efficacy and tolerability of two types of basal-bolus therapy , using either the soluble long-acting basal insulin analogue , insulin detemir , in combination with the rapid-acting analogue , insulin aspart , or NPH insulin in combination with mealtime regular human insulin . Methods In this 18-week , 1:1 r and omised , open-labelled , parallel trial , 595 patients with Type 1 diabetes mellitus received insulin detemir or NPH insulin in the morning and at bedtime in combination with mealtime insulin aspart or regular human insulin respectively . Results Glycaemic control with insulin detemir/insulin aspart was improved in comparison with NPH insulin/regular human insulin ( HbA1c : 7.88 % vs 8.11 % ; mean difference : −0.22 % point [ 95 % CI : −0.34 to −0.10 ] ; p<0.001 ) . Self-measured 8-point plasma glucose profiles differed between the groups ( p<0.001 ) , with lower postpr and ial plasma glucose levels in the insulin detemir/insulin aspart group . Within-person day-to-day variation in plasma glucose was lower with insulin detemir/insulin aspart than with NPH insulin/regular human insulin ( SD : 2.88 vs 3.12 mmol/l ; p<0.001 ) . Risk of overall and nocturnal hypoglycaemia ( 23.00–06.00 hours ) was , respectively , 21 % ( p=0.036 ) and 55 % ( p<0.001 ) lower in the insulin detemir/insulin aspart group than in the NPH insulin/regular human insulin group . Body weight ( adjusted for baseline and change in HbA1c ) was 1 kg lower with insulin detemir/insulin aspart than with NPH insulin/regular human insulin ( p<0.001 ) . Conclusions /interpretationBasal-bolus therapy using insulin detemir/insulin aspart offers a better balance of control and tolerability than with NPH insulin/regular human insulin . The low variability and more physiological action profiles generated with these insulin analogues result ed in improved glycaemic control with lower risk of hypoglycaemia and no concomitant body weight increase OBJECTIVE —To assess the safety and efficacy of insulin aspart ( IAsp ) versus regular human insulin ( HI ) in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes . RESEARCH DESIGN AND METHODS —Subjects ( n = 322 ) who were pregnant or planning pregnancy were r and omized to IAsp or HI as meal-time insulin in an open-label , parallel-group , multicenter study . Subjects had A1C ≤8 % at confirmation of pregnancy . Insulin doses were titr Output:	There were insufficient data to determine whether insulin analogues are better than conventional insulins in reducing long-term diabetes-related complications or death . INTERPRETATION Rapid- and long-acting insulin analogues offer little benefit relative to conventional insulins in terms of glycemic control or reduced hypoglycemia .
MS2678	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Kangaroo care ( KC ) has been the intervention for preterm infants in numerous published studies . However , most well design ed studies to date have used a one-group repeated measure design . This methodology is not as definitive as an experimental design . Because of the absence of a comparable control group , change between pretest and posttest may be due to any other environmental variables or normal variation of subjects ( Kirk , 1995 ) . This r and omized controlled trial ( RCT ) was done to test the hypotheses that KC infants would have higher mean tympanic temperatures , less weight loss , more optimal behavioral states , and lower acuity ( length of stay ) . Thirty-four eligible mother-infant dyads were r and omly assigned to the KC or the control group by computerized minimization on the day following birth . Stratification variables included infant gender , birth weight , delivery method , and parity . KC infants compared to control infants had higher mean tympanic temperature ( 37.3 degrees C vs. 37.0 degrees C ) , more quiet sleep ( 62 % vs. 22 % ) , and less crying ( 2 % vs. 6 % ) all at p=.000 . No significant difference was found for weight loss and acuity ( length of stay ) . These findings can be used for evidence -based nursing practice in Taiwan . With the knowledge attained from this RCT , nurses can educate and motivate mothers to keep their stable preterm infants warm by skin-to- skin contact inside their clothing , thereby encouraging self-regulatory feeding Purpose : To compare kangaroo mother care ( KMC ) and conventional cuddling care ( CCC ) in premature and smallfor-gestational-age infants . Design and Sample : Thirty mother-infant dyads in two Australian neonatal nurseries were r and omly assigned to the KMC group or the CCC group . Both groups of mothers cuddled their babies for a minimum of two hours a day , five days a week while in the study , with the KMC group having skin-to-skin contact while the CCC group had contact through normal clothing . Main Outcome Variable : The main outcome variables were infant weight gain , temperature maintenance during KMC and CCC , and length of hospital stay . Results : The results showed no difference between groups on the Parental Stress Scale ( NICU ) or the Parental Expectations Survey . Infants in both groups experienced equivalent maintenance of or rise in temperature while out of the incubators , equal weight gain , equal length of stay in the hospital , and equal duration of breastfeeding BACKGROUND Extremely preterm birth , even in the absence of significant neurological impairment , is associated with altered pain responses and impaired memory and behaviour . Preterm birth increases the risk of maternal depression and may impede the development of the mother-infant relationship , factors that in turn are also associated with impaired infant outcome . Mother-infant skin-to-skin contact has been recommended as a simple means of ameliorating these effects . METHODS We conducted a pragmatic , prospect i ve , controlled , intention-to-treat trial in two neonatal intensive care units . Infants born below 32 weeks gestation were recruited within the first week after birth and assigned to a control group receiving st and ard care , or an intervention group in which mothers were encouraged to provide a session of skin-to-skin contact once daily for 4 weeks . We assessed infant behaviour at time of discharge from hospital , responses to immunisation at 4 and 12 months of age , and memory , behaviour and development at 1 year corrected ( postmenstrual ) age . Indices of maternal depression , stress , anxiety , lactation performance and infant interaction were assessed at time of infant discharge , 4 months and 1 year . RESULTS No significant difference was identified in any infant or maternal measure at any time point . CONCLUSIONS Mother-infant skin-to-skin contact after extremely preterm birth results in neither benefit nor adverse consequences . Although there is no reason to dissuade mothers who wish to provide STS contact , we are unable to recommend re source allocation for the implementation of STS programmes for extremely preterm infants in a neonatal intensive care unit setting Background . Based on the general bonding hypothesis , it is suggested that kangaroo mother care ( KMC ) creates a climate in the family whereby parents become prone to sensitive caregiving . The general hypothesis is that skin-to-skin contact in the KMC group will build up a positive perception in the mothers and a state of readiness to detect and respond to infant 's cues . Method . The r and omized controlled trial was conducted on a set of 488 infants weighing < 2001 g , with 246 in the KMC group and 242 in the traditional care ( TC ) group . The design allows precise observation of the timing and duration of mother – infant contact , and takes into account the infant 's health status at birth and the socioeconomic status of the parents . Bonding Assessment . Two series of outcomes are assessed as manifestations of a mother 's attachment behavior . The first is the mother 's feelings and perceptions of her premature birth experience , including her sense of competence , feelings of worry and stress , and perception of social support . The second outcome is derived from observations of the mother and child 's responsivity to each other during breastfeeding at 41 weeks of gestational age . Interventions . KMC has three components . The first is the kangaroo position . Once the premature infant has adapted to extrauterine life and is able to breastfeed , he is positioned on the mother 's chest , in a upright position , with direct skin-to-skin contact . The second component is kangaroo nutrition . Although breastfeeding is the prime source of nutrition , infants also may receive preterm formula whenever necessary and vitamin supplements . The third component is the clinical control ; infants are monitored on a regular basis , daily until they are gaining at least 20 g per day . Afterward , weekly clinic visits are scheduled until term , which constitutes the ambulatory minimal neonatal care . In the TC group , infants are kept in incubators until they are able to self-regulate their temperature and are thriving ( ie , have an appropriate weight gain ) . Infants are discharged according to current hospital practice , usually not before their weight is ∼1700 g. Afterward , as with the KMC group , weekly clinic visits are scheduled until term . Results . We observed a change in the mothers ' perception of her child , attributable to the skin-to-skin contact in the kangaroo-carrying position . This effect is related to a subjective “ bonding effect ” that may be understood readily by the empowering nature of the KMC intervention . Moreover , in stressful situations when the infant has to remain in the hospital longer , mothers practicing KMC feel more competent than do mothers in the TC group . This is what we call a resilience effect . In these stressful situations we also found a negative effect on the feelings of received support of mothers practicing KMC . We interpret this as an isolation effect . To thwart this deleterious effect , we would suggest adding social support as an integral component of KMC . The observations of the mothers ' sensitive behavior did not show a definite bonding effect , but rather a resilience effect . This is attributable to the KMC intervention ; mothers practicing KMC were more responsive to an at-risk infant whose development has been threatened by a longer hospital stay . Otherwise , we observed that the mothers ( in both the KMC group and the TC group ) had behavioral patterns that were adapted to the child 's at-risk health status and to the precarious condition of some premature infants requiring intensive care . We conclude that the infant 's health status may be a more prominent factor in explaining a mother 's more sensitive behavior , which overshadows the kangaroo-carrying effect . Conclusion . These results suggest that KMC should be promoted actively and that mothers should be encouraged to use it as soon as possible during the intensive care period up to the 40 weeks of gestational age . Thus , KMC should be viewed as a means of humanizing the process of giving birth in a context of prematurity . This finding confirms the conclusions of the 1996 Trieste workshop suggesting that KMC should be promoted both in hospitals and after early discharge OBJECTIVE To evaluate the effects of maternal-infant skin-to-skin contact ( SSC ) vs st and ard contact ( SC ) on low-birth-weight infants ' physiological profile , maternal milk production , and duration of breast-feeding . DESIGN Prospect i ve , r and omized , interventional study with cohort followed up for 6 months after discharge from the hospital . SETTING Special care nursery with follow-up telephone calls after discharge from the hospital . PATIENTS Fifty infants , with birth weights less than 1500 g and whose mothers planned to breast-feed , r and omized to 2 groups : SSC ( experimental ) and SC ( control ) . INTERVENTION In the SSC group , infants were clothed in diaper and held upright between mothers ' breasts ; both mother and infant were covered with a blanket . In the SC group , infants were clothed , wrapped in blankets , and held cradled in mother 's arms . MAIN OUTCOME MEASURES Infant physiological data , ie , oxygen saturation , heart rate , respiratory rate , and axillary temperature ; maternal milk production ; and duration of breast-feeding . RESULTS Oxygen saturation was higher during SSC than during SC ( P < .001 ) ; 11 % of the oxygen saturation recordings during SSC vs 24 % during SC indicated the values less than 90 % ( P < .001 ) . A more stable milk production was noted in the SSC group . No differences were noted in infant temperature , heart rate , or respiratory rate . Ninety percent of mothers in the SSC group vs 61 % in the SC group continued breast-feeding for the duration of the infants ' hospitalization ( P < .05 ) , and 50 % in the SSC group vs 11 % in the SC continued breast-feeding through 1 month after discharge ( P < .01 ) . CONCLUSIONS During SSC with their mothers , low-birth-weight infants maintain a higher oxygen saturation and are less likely to have desaturation to less than 90 % oxygen than are infants exposed to SC . Mothers in the SSC group are more likely to continue breast-feeding until 1 month after discharge OBJECTIVE To test the effects of kangaroo care ( KC ) on breastfeeding outcomes in preterm infants compared with two control groups and to explore whether maternal-infant characteristics and the mother 's choice to use KC were related to breastfeeding measures . DESIGN Secondary analysis of a multisite , stratified , r and omized three-arm trial . The treatment groups used KC , auditory-tactile-visual-vestibular ( ATVV ) intervention , or received preterm infant care information . SETTING Neonatal intensive care units from 4 hospitals in the United States from 2006 to 2011 . PARTICIPANTS Racially diverse mothers ( N = 231 ) and their preterm infants born weighing less than 1,750 g. METHODS Mothers and their infants were enrolled once the infants were no longer critically ill , weighed at least 1,000 g , and could be safely held outside the incubator by parents . Participants were instructed by study nurses ; those allocated to the KC or ATVV groups were asked to engage in these interactions with their infants for a minimum of 3 times a week in the hospital and at home until their infants reached age 2 months adjusted for prematurity . RESULTS Feeding at the breast during hospitalization , the duration of postdischarge breastfeeding , and breastfeeding exclusivity after hospital discharge did not differ statistically among the treatment groups . Regardless of group assignment , married , older , and more educated women were more likely to feed at the breast during hospitalization . Mothers who practice d KC , regardless of r and omly allocated group , were more likely to provide their milk than those who did not practice KC . Breastfeeding duration was greatest among more educated women . CONCLUSION As implemented in this study , assignment to the KC group did not appear to influence the measured breastfeeding outcomes OBJECTIVE To investigate the feasibility and safety of skin-to-skin care after birth for moderately preterm infants . DESIGN Prospect i ve cohort study . SETTING The study was conducted at the maternity wards and NICUs of three study sites in Norway . PARTICIPANTS Ninety preterm infants born vaginally with gestational ages of 32 weeks/0 days to 34 weeks/6 days . METHODS Comparison of groups of preterm infants who received skin-to-skin care or conventional treatment in incubators after birth . RESULTS Median gestational age and birth weight were similar in the two groups : 33 weeks/5 days versus 34 weeks/3 days ( p = .464 ) and 2,100 versus 2,010 g ( p = .519 ) . There were no differences in the first body temperature ( p = .841 ) and blood glucose level ( p = .539 ) between the groups . CONCLUSION Early skin-to-skin contact in the delivery room for moderately preterm infants may be feasible and safe Purpose : To determine the effects of kangaroo care ( KC ) ( skin-to-skin contact ) on breastfeeding status in mother – preterm infant dyads from postpartum through 18 months . Design : R and omized , controlled trial . The control group received st and ard nursery care ; in the intervention group , unlimited KC was encouraged . Sample : A sub sample of 66 mothers and their preterm infants ( 32–36 completed weeks gestation , 1,300–3,000 g , 5 minute Apgar ≥6 ) who intended to breastfeed . Main Outcome Variables : Breastfeeding status at hospital discharge and at 1.5 , 3 , 6 , 12 , and 18 months as measured by the Index of Breastfeeding Status . Results : KC dyads , compared to control dyads , breastfed significantly longer ( 5.08 months vs 2.05 months ) , p = .003 . KC dyads also breastfed more exclusively at each measurement , p = .04 Output:	Sensitivity analysis suggested that inclusion of studies with high risk of bias did not affect the general direction of findings nor the size of the treatment effect for main outcomes .
MS2679	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The prognostic value of immunosuppressive acidic protein ( IAP ) , which is known to suppress various immune responses in cancer patients , was studied in a prospect i ve r and omized trial of advanced gastric cancer patients , design ed to evaluate the effect of PSK , a kind of biological response modifier with protein-bound polysaccharides . Preoperative serum IAP levels were determined in 228 patients who received radical gastric resection and tests conducted in one laboratory by the single radial immunodiffusion ( SRID ) method . All patients were followed up for 24 months or more . There was an overall significant difference in disease-free survival time in favour of the PSK-treated group compared with the control group . Preoperative IAP values were strongly associated with disease-free survival time . The statistical analysis to define an appropriate cut-off level for IAP was performed using Cox 's proportional hazards model . The most significant difference was observed at the threshold value of 580 μg/ml , the hazard ratio being 2.13 with a 95 % confidence interval [ 1.17 , 3.88 ] ( P=0.013 ) . Patients in the PSK-treated group with a preoperative IAP of lower than 580 μg/ml showed improved disease-free survival ( P=0.029 ) , however , no significant difference was seen between the two groups when the preoperative IAP exceeded the threshold level . From these results , 580 μg/ml is postulated to be the most appropriate threshold value for predicting the prognosis of advanced gastric cancer patients , and it is suggested that PSK would be most effective in patients whose preoperative IAP level is lower than the threshold level Protein-bound polysaccharide K ( PSK ) increased the 5-year disease-free survival rate and reduced the risk of recurrence in a r and omised , controlled study for stage II and III colorectal cancer . In order to eluci date the disease-free survival benefits with PSK and what immunological markers could indicate a PSK responder , serial changes in immunological parameters were monitored in the study . PSK decreased the mean serum immunosuppressive acidic protein ( IAP ) level , and increased the mean population of natural killer ( NK ) cells compared with the controls . The 5-year disease-free and overall survival rate for patients with serum IAP values < or=500 microg ml(-1 ) , which represents the normal value , were 75.5 % ( 95 % CI : 66.8 - 84.2 % ; p=0.016 ) and 85.1 % ( 95 % CI : 77.9 - 92.3 % ; p=0.032 ) , respectively , in the PSK group compared with 57.5 % ( 95 % CI : 43.3 - 71.6 % ) and 70.2 % ( 95 % CI : 57.1 - 83.3 % ) in the control group . In patients with NK cell population > or=8 % at 3 months after surgery , PSK conferred a significantly better ( p=0.038 ) 5-year disease-free survival ( 86.7 % ; 95 % CI : 74.5 - 98.8 % ) compared to the control group ( 60.0 % ; 95 % CI : 29.6 - 90.4 % ) . In the proportional hazards model , the presence of regional metastases ( relative risk , 3.595 ; 95 % CI : 1.518 to 8.518 ; p=0.004 ) and omission of PSK treatment ( relative risk , 3.099 ; 95 % CI : 1.202 to 7.990 ; p=0.019 ) were significant indicators of recurrence . PSK acts as an immunomodulatory activity and biochemical modulator in stage II or III colorectal cancer . Pre-operative serum IAP values < or=500 microg ml(-1 ) and an NK cell population > or=8 % at 3 months after surgery are possible PSK response predictors Intravenous fluorouracil and leucovorin is the st and ard adjuvant treatment for stage III colon cancer . However , oral adjuvant chemotherapy is attractive because it has low toxicity and greater convenience . We investigated the benefits of oral protein-bound polysaccharide K ( PSK ) with tegafur/uracil ( UFT ) as an adjuvant in stage II and III colorectal cancer . Patients were assigned to groups that received either 3 g PSK plus 300 mg UFT , or 300 mg UFT alone orally each day for a 2-year period following intravenous mitomycin C. Of 207 registered patients , 205 with stage II ( n=123 ) or III ( n=82 ) were analysed . The 5-year disease-free survival was 73.0 % ( 95 % CI 65.6–80.4 % ) with PSK ( n=137 ) and 58.8 % ( 95 % CI 47.1–70.5 % ) in the controls ( n=68 ) ( P=0.016 ) . Polysaccharide K reduced the recurrence by 43.6 % ( 95 % CI 4.5–66.7 % ) and mortality by 40.2 % ( 95 % CI −12.5 to 68.3 % ) . The 5-year survival was 81.8 % ( 95 % CI 75.3–88.2 % ) in the PSK group and 72.1 % ( 95 % CI 61.4–82.7 % ) in the control group ( P=0.056 ) . In stage III patients , disease-free and overall survivals in patients receiving PSK were increased significantly : 60.0 % ( 95 % CI 47.1–72.9 % ) and 74.6 % ( 95 % CI 63.0–86.1 % ) in the PSK group as compared with 32.1 % ( 95 % CI 14.8–49.4 % ) and 46.4 % ( 95 % CI 28.0–64.9 % ) in the controls ( P=0.002 and 0.003 , respectively ) . Polysaccharide K prevented recurrence , particularly lung metastases ( P=0.02 ; odds ratio 0.27 ; 95 % CI 0.09–0.77 ) . In the models , the presence of regional metastases ( relative risk , 2.973 ; 95 % CI 1.712–5.165 ; P<0.001 ) , omission of PSK ( relative risk , 2.106 ; 95 % CI 1.221–3.633 ; P=0.007 ) , and higher primary tumour ( relative risk , 4.398 ; 95 % CI 1.017–19.014 ; P=0.047 ) were each significant indicators of recurrence . Adverse effects were mild and compliance was good . Oral PSK with UFT reduced recurrence in stage II and III colorectal cancer , and increased survival in stage III Background Protein-bound polysaccharide ( PSK ) is derived from the CM-101 strain of the fungus Coriolus versicolor and has shown anticancer activity in vitro and in in vivo experimental models and human cancers . Several r and omized clinical trials have demonstrated that PSK has great potential in adjuvant cancer therapy , with positive results in the adjuvant treatment of gastric , esophageal , colorectal , breast and lung cancers . These studies have suggested the efficacy of PSK as an immunomodulator of biological responses . The precise molecular mechanisms responsible for its biological activity have yet to be fully eluci date d. Methods The in vitro cytotoxic anti-tumour activity of PSK has been evaluated in various tumour cell lines derived from leukaemias , melanomas , fibrosarcomas and cervix , lung , pancreas and gastric cancers . Tumour cell proliferation in vitro was measured by BrdU incorporation and viable cell count . Effect of PSK on human peripheral blood lymphocyte ( PBL ) proliferation in vitro was also analyzed . Studies of cell cycle and apoptosis were performed in PSK-treated cells . Results PSK showed in vitro inhibition of tumour cell proliferation as measured by BrdU incorporation and viable cell count . The inhibition ranged from 22 to 84 % . Inhibition mechanisms were identified as cell cycle arrest , with cell accumulation in G0/G1 phase and increase in apoptosis and caspase-3 expression . These results indicate that PSK has a direct cytotoxic activity in vitro , inhibiting tumour cell proliferation . In contrast , PSK shows a synergistic effect with IL-2 that increases PBL proliferation . Conclusion These results indicate that PSK has cytotoxic activity in vitro on tumour cell lines . This new cytotoxic activity of PSK on tumour cells is independent of its previously described immunomodulatory activity on NK cells Background : Despite the small but significant survival benefit of adjuvant chemotherapy in locally advanced gastric cancer ( LAGC ) , the optimal regimen remains to be determined . We conducted a r and omized trial comparing oral ( PO ) chemoimmunotherapy ( CITX ) with intravenous ( IV ) CITX in LAGC patients ( stages IB-IIIB ) with curative resection ( ≥ D2 dissection ) . Methods : The patients were r and omized to the IV ( 5-fluorouracil 500 mg/m2 weekly for 24 weeks , mitomycin-C 8 mg/m2 every 6 weeks × 4 ) or the PO ( uracil-ftorafur ( UFT ) 400 - 600 mg/day for 12 months ) group . Patients in both groups received PO polysaccharide-K ( 3 g/day for 4 months ) . The planned number of patients was 368 for proving the non-inferiority of PO CITX compared to IV CITX for overall survival . Results : The trial was closed prematurely after enrolling 82 patients ( 44 in the IV group , 38 in the PO group ) . With a median follow-up of 82 months , there were no significant differences in the 5-year disease-free survival ( 73 % vs. 55 % , p = 0.358 ) and overall survival ( 77 % vs. 66 % , p = 0.159 ) between the 2 groups . The IV group demonstrated a higher incidence of grade 2 or 3 neutropenia , thrombocytopenia , and vomiting . Conclusions : PO CITX with UFT appeared to be at least non-inferior to 5-fluorouracil and mitomycin-C CITX , with lower toxicity in the adjuvant treatment for LAGC Summary To examine the clinical efficacy and the mechanism of action of polysaccharide K ( PSK ) , a proteinbound polysaccharide extracted from a Basidiomycetes fungus , a r and omized double-blind trial was performed by administering PSK to 56 patients and a placebo to another group of 55 patients after surgical operations on their colorectal cancers . The rate of patients in remission ( or disease-free ) was significantly higher in the PSK group than in the placebo group ; the difference between both groups was statistically significant atP < 0.05 by the logrank test . The survival rate of patients was also significantly ( P < 0.05 ) higher in the PSK group than in the control group . The most significant laboratory finding was that polymorphonuclear leukocytes from PSK-treated patients showed remarkable enhancement in their activities , such as r and om and /or chemotactic locomotion , and phagocytic activity , when compared with those in the control group . In conclusion , PSK was useful as a maintenance therapy for patients after their curative surgical operations for colorectal cancer . The beneficial effects were probably due to the activation of leukocyte functions as one of the many biological-response-modifying ( activities induced by PSK ) Abstract PURPOSE : Intravenous fluorouracil and leucovorin for six to eight months is currently a st and ard adjuvant treatment for Stage III colon cancer ; however , this regimen is complex , inconvenient , and has a high intolerability . Adjuvant chemotherapies are cl aim ed for objective response rates with an acceptable safety profile and complexity . We investigated the benefits of oral protein-bound polysaccharide K added to oral tegafur/uracil on curatively resected Stage II or III colorectal cancer . METHODS : We prospect ively r and omized 207 patients to treatments of either oral 3.0 g protein-bound polysaccharide K plus 300 mg tegafur/uracil or 300 mg tegafur/uracil alone for two years following 12 mg/m2 and 8 mg/m2 mitomycin treatment on postoperative Days 1 and 2 , respectively . The primary end points were disease-free and overall survival , and recurrence rates . RESULTS : Three ( 1.4 percent ) patients were declared ineligible , and three patients did not start treatment . In total , 201 patients were analyzed . The three-year , disease-free survival rate was 80.6 percent ( st and ard error = 3.4 percent ) in the protein-bound polysaccharide K group ( P = 0.02 ) compared with 68.7 percent ( SE = 5.7 percent ) in the control group after a median follow-up of 3.7 years . The estimated relative risk of recurrence in the control group was 1.87 ( 95 percent confidence interval , 1.10–3.20 ) at three years Output:	PSK treatment significantly increased 1 - 5 year OS and result ed in positive trends in 6 - 7 year OS ; significant increases were also found in 1 - 7 year DFS , while no increase in side effects was observed . Significant efficacy outcomes obvious in colorectal and gastric cancer groups , as well as PSK combined with chemotherapy groups ( iv , po , iv+po ) . Network meta- analysis revealed that PSK combined with chemotherapy was superior , with significantly increased 3-year and 5-year OS . The study is registered with PROSPERO ( CRD42017065193 ) Conclusions : The adjuvant immunochemotherapy agent PSK is effective and safe for patients with GIC . PSK combined with chemotherapy appears to be the preferred application of PSK
MS2680	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Treatment of osteitis after surgical removal of the third molar of the m and ible is still a clinical problem . A total of 140 patients undergoing operations for removal of an impacted third molar of the m and ible , were included in a double-blind study . Placebo or antibiotics - azidocillin , erythromycin , clindamycin and doxycycline - were given to the patients preoperatively and for the following 7 days . The concentrations in serum , alveolar serum and m and ibular bone were measured and the postoperative courses - pain , trismus , swelling and wound-healing - were recorded . No correlation was obtained between the antibiotic concentration and the postoperative complaints , except in the azidocillin group on day 2 , in which fewer complaints were noticed in patients with high concentrations of the drug at the time of operations . The 80 patients in the antibiotic groups responded significantly better with respect to wound-healing than the 60 patients in the placebo groups . Only 15 operations lasted more than 15 min and the three of them which subsequently result ed in alveolitis were in the placebo groups . Antibiotics significantly reduced pain on day 7 postoperatively . In general , no statistically significant differences in trismus and swelling could be demonstrated between the patient groups . However , there was a significant difference between the placebo and doxycycline groups with respect to swelling ( day 2 postoperative , P < 0.01 ; day 5 postoperative , P < 0.05 ) . Thus systemically administered antibiotics offered only slight advantages in routine operations of impacted third m and ibular molars , but could decrease the rate of infections after traumatic operations OBJECTIVES The purpose s of this study were to evaluate the use of 0.12 % chlorhexidine gluconate as a prophylactic therapy for the prevention of alveolar osteitis and to further examine subject-based risk factors associated with alveolar osteitis . STUDY DESIGN The trial was a r and omized , double-blind , placebo-controlled , parallel-group study conducted among 279 subjects , each of whom required oral surgery for the removal of a minimum of one impacted m and ibular third molar . Subjects were instructed to rinse twice daily with 15 ml of chlorhexidine or placebo mouthrinse for 30 seconds for 1 week before and 1 week after the surgical extraction s. This regimen included a supervised presurgical rinse . Alveolar osteitis diagnosis was based on the subjective finding of increasing postoperative pain at the surgical site that was not relieved with mild analgesics , supported by clinical evidence of one or more of the following : loss of blood clot , necrosis of blood clot , and exposed alveolar bone . RESULTS In comparison with use of the placebo mouthrinse , prophylactic use of the chlorhexidine mouthrinse result ed in statistically significant ( p < 0.05 ) reductions in the incidence of alveolar osteitis . With chlorhexidine therapy , the subject- and extraction -based incidences of alveolar osteitis in the evaluable subset ( 271 subjects ) were reduced , relative to placebo , by 38 % and 44 % , respectively . The corresponding odds ratios that describe the increased odds of experiencing alveolar osteitis in the placebo group were 1.87 and 2.05 for subject- and extraction -based analyses , respectively . In comparison with nonuse of oral contraceptives , the use of oral contraceptives in female subjects was related to a statistically significant increase in the incidence of alveolar osteitis ( odds ratio = 1.92 , p = 0.035 ) . Relative to male subjects , the observed incidence of alveolar osteitis for female subjects not using oral contraceptives was not statistically significant ( odds ratio = 1.18 , p = 0.64 ) . Smoking did not increase the incidence of alveolar osteitis relative to not smoking ( odds ratio = 1.20 , p = 0.33 ) . CONCLUSIONS These data confirm that the prophylactic use of 0.12 % chlorhexidine gluconate mouthrinse results in a significant reduction in the incidence of alveolar osteitis after the extraction of impacted m and ibular third molars . In addition , oral contraceptive use in females was confirmed to be a risk factor for the development of alveolar osteitis A double-blind study evaluated the ability of 0.12 % chlorhexidine rinse to decrease the incidence of localized alveolar osteitis after the removal of m and ibular third molar teeth . One hundred sixty extraction sites in 80 patients were evaluated . A statistically significant decrease in the incidence of dry socket was seen in patients using the chlorhexidine rinse with no significant adverse reactions . Thus a 0.12 % chlorhexidine rinse is shown to be an effective means of decreasing alveolar osteitis that may follow removal of third molar teeth OBJECTIVE The purpose of this study was to evaluate whether immediate placement of medicated dry socket packing would decrease the incidence of alveolar osteitis ( dry socket ) with lower third molar extraction s. STUDY DESIGN In 100 patients , 200 lower third molars were extracted . One half of the sockets were packed to the crest of the alveolar ridge with a one-quarter-inch radiograph-detectable filament gauze that contained 9 % eugenol , 36 % balsam of Peru , and 55 % petroleum jelly . The medicated packing was removed 1 week after surgery . None of the patients were taking antibiotics . Patients were instructed to increase their oral hygiene before and after surgery and were to use 0.12 % chlorhexidine gluconate 2 days before and 3 days after surgery . RESULTS ; Two hundred bilateral lower third molars of varying difficulty were extracted . The overall alveolar osteitis rate was 34 ( 17 % ) . The immediately packed lower third molar sites had an alveolar osteitis rate of 8 ( 8 % ) . The sockets that were not packed with medicated packing the day of surgery had an alveolar osteitis rate of 26 ( 26 % ) . The difference was statistically significant ( P = .001 ) . CONCLUSION The results of this study suggest that placement of medicated dry socket packing immediately after lower third molar extraction decreases the alveolar osteitis rate PURPOSE This study evaluated the efficacy of topical viscous 2 % lidocaine jelly for the alleviation of pain experienced during the instrumentation of m and ibular third molar extraction sites diagnosed with alveolar osteitis and for pain relief during the postinstrumentation period . PATIENTS AND METHODS Thirty adult patients with a diagnosis of alveolar osteitis in a m and ibular third molar extraction site were included in this prospect i ve , double-blind study . Each patient had their sutures removed , the socket irrigated , and 2 % lidocaine jelly placed on the tip and side of the tongue to blind the patient against the test substances . The subjects were then r and omly distributed into two groups . Group 1 had a nonactive jelly base placed into the socket 2 minutes prior to the placement of a st and ard obtundant dressing . Group 2 had viscous 2 % lidocaine jelly placed into the socket in the same manner . Patients subjectively quantified their pain intensity pretreatment , during instrumentation , immediately postmanipulation , at 5-minute intervals to 30 minutes , and at 45 and 60 minutes . They also subjectively quantified their pain relief at each of the time intervals following instrumentation . RESULTS There was no statistical difference between the pretreatment pain experienced by both groups . The use of 2 % lidocaine jelly had a measurable ( P = .056 ) , but not statistically significant , effect on pain due to instrumentation . At every time interval thereafter , the use of 2 % lidocaine jelly elicited a statistically significant ( P < .05 ) decrease in pain perception , and a statistically significant increase in pain relief when compared with the inactive jelly . CONCLUSION Topical viscous 2 % lidocaine jelly is a useful adjunct during the treatment of alveolar osteitis , especially in the early ( < or = 60 minutes ) postinstrumentation period The incidence of alveolar osteitis can be reduced significantly by lavage of the oral cavity and the area around the lower third molar with an antiseptic mouthwash before extraction . Evaluation of m and ibular third molar extraction s provides indications of preventive measures to avoid the occurrence of alveolar osteitis . A group of r and omly selected patients was given an oral lavage with a phenolated antiseptic mouthwash before extraction . The use of an oral lavage before extraction result ed in fewer instances of alveolar osteitis than in extraction s that were not preceded by lavage Prophylactic metronidazole was found to be an effective means of preventing ' dry socket ' after routine dental extraction s. The oral anaerobic bacterial may be implicated therefore in the development of the disorder . It has been confirmed in this study that ' dry socket ' occurs following three per cent of routine dental extraction s and almost exclusively in the m and ible . The causes of the condition are probably numerous and may even vary from patient to patient , but the control of infection by anerobic organisms may be important in its prevention or early resolution . The prophylactic administration of metronidazole ( Flagyl ) has been shown to be a simple and effective method of prevention which would suggest the implication of anaerobic organisms in ' dry socket ' . The drug appears to be free from side effects when a dosage of 200 mgs eight hourly for three days is given Abstract Gelfoam saturated with sterile lincomycin solution was effective in the reduction of dry socket in subjects who had undergone extraction of impacted m and ibular third molars . The occurrence of dry socket was reduced to 1.1 per cent in the patients who received topical lincomycin in Gelfoam , as compared to 7.8 per cent when the Gelfoam contained saline solution instead of lincomycin Output:	RESULTS Prevention methods remain the key to avoiding this complication . Prophylactic placement of topical antibiotics can be considered , whereas systemic antibiotics should be reserved for patients who are immunocompromised . This paper provided a comprehensive review of the etiology , pathophysiology , and current treatment of dry socket in dental practice
MS2681	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The development of tumor biomarkers ready for clinical use is complex . We propose a refined system for biomarker study design , conduct , analysis , and evaluation that incorporates a hierarchal level of evidence scale for tumor marker studies , including those using archived specimens . Although fully prospect i ve r and omized clinical trials to evaluate the medical utility of a prognostic or predictive biomarker are the gold st and ard , such trials are costly , so we discuss more efficient indirect " prospect ive-retrospective " design s using archived specimens . In particular , we propose new guidelines that stipulate that 1 ) adequate amounts of archived tissue must be available from enough patients from a prospect i ve trial ( which for predictive factors should generally be a r and omized design ) for analyses to have adequate statistical power and for the patients included in the evaluation to be clearly representative of the patients in the trial ; 2 ) the test should be analytically and preanalytically vali date d for use with archived tissue ; 3 ) the plan for biomarker evaluation should be completely specified in writing before the performance of biomarker assays on archived tissue and should be focused on evaluation of a single completely defined classifier ; and 4 ) the results from archived specimens should be vali date d using specimens from one or more similar , but separate , studies Purpose : Plasma proteins [ vascular endothelial growth factor ( VEGF ) , soluble VEGF receptor 2 ( sVEGFR-2 ) , carbonic anhydrase IX ( CAIX ) , tissue inhibitor of metalloproteinase 1 ( TIMP-1 ) , and Ras p21 ] and one tumor gene ( VHL ) were analyzed to identify prognostic biomarkers or indicators of response to sorafenib in a subset of patients enrolled in the Treatment Approaches in Renal Cancer Global Evaluation Trial . Experimental Design : Nine hundred three patients with advanced renal cell carcinoma ( RCC ) were r and omized to 400 mg sorafenib twice a day or placebo . Sample s collected at baseline and after 3 and 12 weeks were subjected to enzyme-linked immunosorbent assays . VHL exons were sequenced from tumor biopsies . Results : Baseline biomarker data were available for VEGF ( n = 712 ) , sVEGFR-2 ( n = 713 ) , CAIX ( n = 128 ) , TIMP-1 ( n = 123 ) , Ras p21 ( n = 125 ) , and VHL mutational status ( n = 134 ) . Higher Eastern Cooperative Oncology Group performance status ( ECOG PS ) score correlated with elevated baseline VEGF ( P < 0.0001 ) and a higher incidence of VHL mutations ( P = 0.008 ) , whereas higher Memorial Sloan-Kettering Cancer Center ( MSKCC ) score correlated with elevated VEGF ( P < 0.0001 ) , CAIX ( P = 0.027 ) , and TIMP-1 ( P = 0.0001 ) . Univariable analyses of baseline levels in the placebo cohort identified VEGF ( P = 0.0024 ) , CAIX ( P = 0.034 ) , TIMP-1 ( P = 0.001 ) , and Ras p21 ( P = 0.016 ) as prognostic biomarkers for survival . TIMP-1 remained prognostic for survival in a multivariable analysis model ( P = 0.002 ) that also included ECOG PS , MSKCC score , and the other biomarkers assayed . In the placebo cohort , TIMP-1 ( P < 0.001 ) and Ras p21 ( P = 0.048 ) levels increased at 12 weeks . In the sorafenib cohort , VEGF levels increased at 3 and 12 weeks of treatment ( both weeks P < 0.0001 ) , whereas sVEGFR-2 ( both weeks P < 0.0001 ) and TIMP-1 levels ( P = 0.002 , week 3 ; P = 0.006 , week 12 ) decreased . Conclusions : VEGF , CAIX , TIMP-1 , and Ras p21 levels were prognostic for survival in RCC patients . Of these , TIMP-1 has emerged as being independently prognostic . Clin Cancer Res ; 16(19 ) ; 4853–63 . © 2010 AACR BACKGROUND Previous studies suggest that expression of hypoxia markers may be associated with response to antiangiogenic drugs . Thus , we aim ed to identify predictors of sunitinib outcome in clear-cell renal cell carcinoma ( ccRCC ) . PATIENTS AND METHODS The expression of eight key proteins related to hypoxia ( CAIX , HIF1A , HIF2A , VEGFA , VEGFR1 , VEGFR2 , VEGFR3 and PDGFRB ) and P-glycoprotein were assessed by immunohistochemistry in 67 primary ccRCC sample s from prospect ively recruited patients treated with first-line sunitinib . The proteins expression , VHL inactivation and EGLN3 mRNA content were compared with the patients ' response to sunitinib . RESULTS High expression of HIF2A and PDGFRB was associated with better sunitinib RECIST objective response ( P = 0.024 and P = 0.026 ; respectively ) and increased VEGFR3 expression was associated with longer progression-free survival ( P = 0.012 ) . VEGFR3 overexpression showed a negative correlation with VEGFR3 polymorphism rs307826 ( P = 0.002 ) , a sunitinib resistance predictor . With respect to overall survival ( OS ) , high VEGFA was associated with short ( P = 0.009 ) and HIF2A with long ( P = 0.048 ) survival times . High EGLN3 mRNA content was associated with shorter OS ( P = 0.023 ) . CONCLUSIONS We found an association between several proteins involved in hypoxia and sunitinib efficacy . In addition , low VEGFR3 expression was associated with worse outcome and with VEGFR3 rs307826 variant allele , reinforcing VEGFR3 as a marker of sunitinib resistance BACKGROUND Metastatic renal cell carcinoma ( mRCC ) patients treated with anti-vascular endothelial growth factor ( VEGF ) therapies demonstrate promising outcomes but not all patients benefit . Factors that predict response remain to be eluci date d. PATIENTS AND METHODS Nephrectomy material from 37 patients with mRCC receiving bevacizumab + /- erlotinib was used for protein and gene expression assessment . Protein lysates were subjected to reverse-phase protein array profiling . RNA extracts were used to carry out gene expression microarray-based profiling . Normalized protein and gene expression data were correlated with overall survival ( OS ) and progression-free survival ( PFS ) using univariate Cox hazard model and linear regression . Immunoblotting was carried out to vali date the results . RESULTS High protein levels of AMP-activated protein kinase and low levels of cyclin B1 ( CCNB1 ) were associated with longer OS and PFS . Further validation revealed reduced expression and activation of phosphoinositide 3-kinase ( PI3 K ) pathway components and cell cycle factors in patients with prolonged survival after therapy . Gene expression analysis revealed up-regulation of PI3K- and cell cycle-related pathways in patients with shorter PFS . CONCLUSIONS The OS and PFS of bevacizumab + /- erlotinib-treated patients with renal cell carcinoma were associated with changes in expression of protein and gene expression markers related to PI3 K pathway and cell cycle signaling BACKGROUND We conducted a phase 3 , r and omized , double-blind , placebo-controlled trial of sorafenib , a multikinase inhibitor of tumor-cell proliferation and angiogenesis , in patients with advanced clear-cell renal-cell carcinoma . METHODS From November 2003 to March 2005 , we r and omly assigned 903 patients with renal-cell carcinoma that was resistant to st and ard therapy to receive either continuous treatment with oral sorafenib ( at a dose of 400 mg twice daily ) or placebo ; 451 patients received sorafenib and 452 received placebo . The primary end point was overall survival . A single planned analysis of progression-free survival in January 2005 showed a statistically significant benefit of sorafenib over placebo . Consequently , crossover was permitted from placebo to sorafenib , beginning in May 2005 . RESULTS At the January 2005 cutoff , the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group ( hazard ratio for disease progression in the sorafenib group , 0.44 ; 95 % confidence interval [ CI ] , 0.35 to 0.55 ; P<0.01 ) . The first interim analysis of overall survival in May 2005 showed that sorafenib reduced the risk of death , as compared with placebo ( hazard ratio , 0.72 ; 95 % CI , 0.54 to 0.94 ; P=0.02 ) , although this benefit was not statistically significant according to the O'Brien-Fleming threshold . Partial responses were reported as the best response in 10 % of patients receiving sorafenib and in 2 % of those receiving placebo ( P<0.001 ) . Diarrhea , rash , fatigue , and h and -foot skin reactions were the most common adverse events associated with sorafenib . Hypertension and cardiac ischemia were rare serious adverse events that were more common in patients receiving sorafenib than in those receiving placebo . CONCLUSIONS As compared with placebo , treatment with sorafenib prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed ; however , treatment is associated with increased toxic effects . ( Clinical Trials.gov number , NCT00073307 [ Clinical Trials.gov ] . ) BACKGROUND No biomarkers that could guide patient selection for treatment with the anti-VEGF monoclonal antibody bevacizumab have been identified . We assessed whether genetic variants in the VEGF pathway could act as biomarkers for bevacizumab treatment outcome . METHODS We investigated DNA from white patients from two phase 3 r and omised studies . In AViTA , patients with metastatic pancreatic adenocarcinoma were r and omly assigned to receive gemcitabine and erlotinib plus either bevacizumab or placebo . In AVOREN , patients with metastatic renal-cell carcinoma were r and omly assigned to receive interferon alfa-2a plus either bevacizumab or placebo . We assessed the correlation of 138 SNPs in the VEGF pathway with progression-free survival and overall survival in a sub population of patients from AViTA . Significant findings were confirmed in a sub population of patients from AVOREN and functionally studied at the molecular level . FINDINGS We investigated DNA of 154 patients from AViTA , of whom 77 received bevacizumab , and 110 patients from AVOREN , of whom 59 received bevacizumab . Only rs9582036 , a SNP in VEGF receptor 1 ( VEGFR1 or FLT1 ) , was significantly associated with overall survival in the bevacizumab group of AViTA after correction for multiplicity ( per-allele hazard ratio [ HR ] 2·1 , 95 % CI 1·45 - 3·06 , p=0·00014 ) . This SNP was also associated with progression-free survival ( per-allele HR 1·89 , 1·31 - 2·71 , p=0·00081 ) in bevacizumab-treated patients from AViTA . AC and CC carriers of this SNP exhibited HRs for overall survival of 2·0 ( 1·19 - 3·36 ; p=0·0091 ) and 4·72 ( 2·08 - 10·68 ; p=0·0002 ) relative to AA carriers . No effects were seen in placebo-treated patients and a significant genotype by treatment interaction ( p=0·041 ) was recorded , indicating that the VEGFR1 locus containing this SNP serves as a predictive marker for bevacizumab treatment outcome in AViTA . Fine-mapping experiments of this locus identified rs7993418 , a synonymous SNP affecting tyrosine 1213 in the VEGFR1 tyrosine-kinase domain , as the functional variant underlying the association . This SNP causes a shift in codon usage , leading to increased VEGFR1 expression and downstream VEGFR1 signalling . This VEGFR1 locus correlated significantly with progression-free survival ( HR 1·81 , 1·08 - 3·05 ; p=0·033 ) but not overall survival ( HR 0·91 , 0·45 - 1·82 , p=0·78 ) in the bevacizumab group in AVOREN . INTERPRETATION A locus in VEGFR1 correlates with increased VEGFR1 expression and poor outcome of bevacizumab treatment . Prospect i ve assessment is underway to vali date the predictive value of this novel biomarker . FUNDING F Hoffmann-La Roche Anti-angiogenic therapy benefits many patients with advanced renal cell carcinoma ( Output:	IL-6 is the most corroborated predictive biomarker based on its consistent predictive value in two different trials .
MS2682	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: CONTEXT R and omized controlled trials have been developed essentially in the context of pharmacological treatments ( ie , oral drugs ; intra-articular injection ; and topical , intramuscular , and intravenous treatments ) , but assessment of the effectiveness of nonpharmacological treatments ( ie , surgery , arthroscopy , joint lavage , rehabilitation , acupuncture , and education ) presents specific issues . OBJECTIVES To compare the quality of articles of nonpharmacological and pharmacological treatments of hip and knee osteoarthritis and to identify specific method ological issues related to assessment of nonpharmacological treatments . DESIGN AND SETTING We search ed MEDLINE and the Cochrane Central Register of Controlled Trials for articles of r and omized controlled trials published between January 1 , 1992 , and February 28 , 2002 , in 28 general medical and specialty journals with high impact factors and assessing nonpharmacological and pharmacological treatments in patients with hip or knee osteoarthritis . MAIN OUTCOME MEASURES The quality of the methods reported in the selected articles was assessed by 2 independent review ers using the Jadad scale , the Delphi list , and guidelines found in the Users ' Guides to the Medical Literature . Investigators also used a checklist of items developed by the authors to analyze study characteristics . RESULTS A total of 110 articles were included in the analysis ; 50 ( 45.5 % ) assessed nonpharmacological treatments and 60 ( 54.5 % ) assessed pharmacological treatments . Reports of nonpharmacological treatments had a lower global quality score than did reports of pharmacological treatments as measured by the Jadad scale ( mean [ SD ] score , 1.4 [ 1.3 ] vs 3.0 [ 1.3 ] ) and the Delphi list ( mean [ SD ] score , 5.2 [ 1.5 ] vs 7.5 [ 1.1 ] ) . Lack of reporting adequate r and om sequence generation and intention-to-treat analyses were found in both nonpharmacological and pharmacological articles . Nonpharmacological treatments were less often compared with a placebo than were pharmacological treatments ( 28.0 % of articles vs 71.7 % ) . Compared with pharmacological articles , nonpharmacological articles less often described blinding of patients ( 26.0 % vs 96.7 % ) , care providers ( 6.0 % vs 81.7 % ) , and outcome assessors ( 68.0 % vs 98.3 % ) . Care providers ' skill levels could influence treatment effect in 84.0 % of nonpharmacological articles vs 23.3 % of pharmacological articles . CONCLUSIONS In this analysis of reports of hip and knee osteoarthritis therapy , nonpharmacological articles scored lower than pharmacological articles in terms of quality . Assessment s of nonpharmacological treatments must take into consideration additional method ological issues The present study investigated whether football has favorable effects in the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men . Twenty-five untrained males aged 31 - 54 year with mild-to-moderate hypertension were r and omized to a football training group ( FTG , two 1-h sessions per week ) and a control group receiving physician-guided traditional recommendations on cardiovascular risk factor modification ( doctoral advice group , DAG ) . After 3 months , systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) were lowered ( P<0.05 ) by 12 + /- 3 and 7 + /- 1 mmHg in FTG , respectively , whereas no significant changes were observed for DAG , with the 3 months values being lower ( P<0.05 ) in FTG than DAG ( SBP : 138 + /- 2 vs 148 + /- 2 mmHg ; DBP : 84 + /- 2 vs 92 + /- 2 mmHg ) . The resting heart rate was lowered ( P<0.05 ) by 12 + /- 2 b.p.m . in FTG after 3 months ( 67 + /- 3 vs 79 + /- 3 b.p.m . ) , whereas no change was observed for DAG . After 3 months , FTG had higher ( P<0.05 ) VO(2max ) ( 8 + /- 2 % ; 35.0 + /- 1.6 vs 32.5 + /- 1.3 mL/min/kg ) and lower ( P<0.05 ) fat mass ( 1.7 + /- 0.6 kg ) , whereas no change was observed for DAG . In conclusion , football training is an attractive non-pharmacological supplement to the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men The effects of 16 weeks of football or strength training on performance and functional ability were investigated in 26 ( 68.2 ± 3.2 years ) untrained men r and omized into a football ( FG ; n = 9 ) , a strength training ( ST ; n = 9 ) , or a control group ( CO ; n = 8) . FG and ST trained 1.6 ± 0.1 and 1.5 ± 0.1 times per week , respectively , with higher ( P < 0.05 ) average heart rate ( HR ) ( ∼140 vs 100 bpm ) and time > 90%HRmax ( 17 vs 0 % ) in FG than ST , and lower ( P < 0.05 ) peak blood lactate in FG than ST ( 7.2 ± 0.9 vs 10.5 ± 0.6 mmol/L ) . After the intervention period ( IP ) , VO₂ max ( 15 % ; P < 0.001 ) , cycle time to exhaustion ( 7 % ; P < 0.05 ) , and Yo-Yo Intermittent Endurance Level 1 performance ( 43 % ; P < 0.01 ) were improved in FG , but unchanged in ST and CO . HR during walking was 12 % and 10 % lower ( P < 0.05 ) in FG and ST , respectively , after IP . After IP , HR and blood lactate during jogging were 7 % ( P < 0.05 ) and 30 % lower ( P < 0.001 ) in FG , but unchanged in ST and CO . Sit-to-st and performance was improved ( P < 0.01 ) by 29 % in FG and 26 % in ST , but not in CO . In conclusion , football and strength training for old men improves functional ability and physiological response to submaximal exercise , while football additionally elevates maximal aerobic fitness and exhaustive exercise performance The study tested the hypothesis that long-term soccer training has positive impact on cardiovascular profile , body composition , bone health , and physical capacity in inactive , pre-menopausal women with mild hypertension . The study applied a r and omized controlled design in which physically inactive middle-aged women were separated into a soccer training group ( n=19 ; SOC ) and a control group ( n=12 ; CON ) . SOC performed 128±29 ( ±SD ) one-h small-sided soccer training sessions over one year . Blood pressure , body composition , blood lipid profile , and fitness level were determined pre- and post-intervention . Over one year , mean arterial pressure decreased more in SOC than in CON ( -5±7 vs + 4±5 mmHg ; P<.05 ) . Total-body fat mass decreased more ( P<.05 ) in SOC than in CON ( -2.5±2.5 vs + 0.6±3.2 kg ; P<.05 ) , while the change scores for lean body mass were not significantly different in SOC ( 2.6±2.7 kg ) compared to CON ( 1.1±1.9 kg , P=.09 ) . Over one year , change scores in whole-body bone mineral density ( 0.004±0.032 vs -0.019±0.026 g·cm2 ) as well as bone mineral content ( 30±70 vs -39±113 g ) were positive in SOC compared to CON ( P<.05 ) . Post-intervention plasma triglycerides decreased more ( -0.1±0.7 vs + 0.2±0.2 mmol·L-1 ) and HDL cholesterol increased more ( 0.2±0.7 vs -0.2±0.2 mmol·L-1 ) in SOC than in CON ( P<.05 ) . Yo-Yo intermittent endurance level 1 ( 122±105 vs 2±21 % ) and 20-m sprint performance ( 6±6 vs -1±2 % ) increased more ( P<.05 ) in SOC than in CON . In conclusion , long-term soccer training result ed in broad-spectrum improvements in the health profile of untrained , pre-menopausal women with mild hypertension , including cardiovascular , metabolic , and musculo-skeletal benefits Summary And rogen deprivation therapy ( ADT ) for prostate cancer ( PCa ) impairs musculoskeletal health . We evaluated the efficacy of 32-week football training on bone mineral density ( BMD ) and physical functioning in men undergoing ADT for PCa . Football training improved the femoral shaft and total hip BMD and physical functioning parameters compared to control . Introduction ADT is a mainstay in PCa management . Side effects include decreased bone and muscle strength and increased fracture rates . The purpose of the present study was to evaluate the effects of 32 weeks of football training on BMD , bone turnover markers ( BTMs ) , body composition , and physical functioning in men with PCa undergoing ADT . Methods Men receiving ADT > 6 months ( n = 57 ) were r and omly allocated to a football training group ( FTG ) ( n = 29 ) practising 2–3 times per week for 45–60 min or to a st and ard care control group ( CON ) ( n = 28 ) for 32 weeks . Outcomes were total hip , femoral shaft , femoral neck and lumbar spine ( L2-L4 ) BMD and systemic BTMs ( procollagen type 1 amino-terminal propeptide , osteocalcin , C-terminal telopeptide of type 1 collagen ) . Additionally , physical functioning ( postural balance , jump height , repeated chair rise , stair climbing ) was evaluated . Results Thirty-two-week follow-up measures were obtained for FTG ( n = 21 ) and for CON ( n = 20 ) , respectively . Analysis of mean changes from baseline to 32 weeks showed significant differences between FTG and CON in right ( 0.015 g/cm2 ) and left ( 0.017 g/cm2 ) total hip and in right ( 0.018 g/cm2 ) and left ( 0.024 g/cm2 ) femoral shaft BMD , jump height ( 1.7 cm ) and stair climbing ( −0.21 s ) all in favour of FTG ( p < 0.05 ) . No other significant between-group differences were observed . Conclusions Compared to st and ard care , 32 weeks of football training improved BMD at clinical ly important femoral sites and parameters of physical functioning in men undergoing ADT for PCa The study examined the effects of 1 year of football or strength training on cardiovascular function in 65- to 75-year-old men . Twenty-six untrained men ( age : 68.2 ± 3.2 years ) were r and omized to football training ( FTG ; n = 9 ) , strength training ( STG ; n = 9 ) , or control ( CG ; n = 8) . In FTG , left ventricular ( LV ) internal diastolic diameter , end-diastolic volume , and mass index were 8 % , 21 % , and 18 % higher ( P < 0.01 ) , respectively , after 12 months , with no changes in STG and CG . After 12 months , LV ejection fraction was increased ( P < 0.05 ) by 8 % and 5 % in FTG and STG , respectively , and systolic longitudinal two-dimensional strain by 8 % and 6 % , whereas right ventricular systolic function improved ( P < 0.05 ) by 22 % in FTG , but not in STG and CG . In FTG , LV diastolic mitral inflow ( E/A ) ratio and peak early diastolic velocity ( E ' ) improved ( P < 0.05 ) by 25 % and 12 % , respectively , after 12 months , with no changes in STG and CG . In FTG , maximum oxygen uptake was 16 % and 18 % higher ( P < 0.001 ) after 4 and 12 months , respectively , and resting heart rate was 6 and 8 beats per minute lower ( P < 0.001 ) , respectively , with no changes in STG and CG . In conclusion , football training elicited superior cardiovascular effects compared with strength training in elderly untrained men Abstract We investigated the musculoskeletal health profile of elite female football players ( ET ) in comparison to untrained ( UT ) young women subjected to 16 weeks of football training ( 2 × 1 h per week ) . DXA scans , blood sampling , sprint testing and Flamingo postural balance testing were carried out for 27 Danish national team players and 28 untrained women , with eight women being tested after training . At baseline total BMD and BMC were 13 % ( 1.305 ± 0.050 versus 1.159 ± 0.056 g Output:	The trials indicate that recreational soccer may result in improvement in cardiovascular function , body composition and functional ability , although no significant changes were observed in postural balance .
MS2683	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND A r and omized phase III trial in high-risk breast cancer patients was conducted , to further explore the impact of dose-density in the adjuvant treatment for breast cancer . The safety analysis is presented . PATIENTS AND METHODS From October 2000 until June 2005 , 1121 node-positive patients were r and omized to sequential dose-dense epirubicin 110 mg/m(2 ) and paclitaxel ( Taxol , Bristol Myers-Squibb , Princeton , New Jersey , USA ) 250 mg/m(2 ) ( group A ) , or concurrent epirubicin 83 mg/m(2 ) and paclitaxel 187 mg/m(2 ) ( group B ) , both followed by three cycles of ' intensified ' combination chemotherapy with cyclophosphamide , methotrexate and fluorouracil ( CMF ) . Granulocyte colony-stimulating factor was given prophylactically with the dose-dense treatments . RESULTS Median dose intensity of epirubicin and paclitaxel was double in group A , as design ed , with significantly less cycles administered at full dose ( P < 0.001 ) . Median cumulative dose of all drugs and total treatment duration , however , were identical between groups . Severe taxane-related toxic effects were more frequent in group A , while severe thrombocytopenia was low and present only in group A. There were no differences in the rates of other hematological toxic effects , including febrile neutropenia . The rates of secondary malignancies were low . CONCLUSION Both regimens as used in the present study are well tolerated and safe . The rates of severe taxane-related toxic effects and thrombocytopenia , although low overall , are significantly increased with the dose-dense sequential regimen PURPOSE This study was design ed to determine whether increasing the dose of doxorubicin in or adding paclitaxel to a st and ard adjuvant chemotherapy regimen for breast cancer patients would prolong time to recurrence and survival . PATIENTS AND METHODS After surgical treatment , 3,121 women with operable breast cancer and involved lymph nodes were r and omly assigned to receive a combination of cyclophosphamide ( C ) , 600 mg/m(2 ) , with one of three doses of doxorubicin ( A ) , 60 , 75 , or 90 mg/m(2 ) , for four cycles followed by either no further therapy or four cycles of paclitaxel at 175 mg/m(2 ) . Tamoxifen was given to 94 % of patients with hormone receptor-positive tumors . RESULTS There was no evidence of a doxorubicin dose effect . At 5 years , disease-free survival was 69 % , 66 % , and 67 % for patients r and omly assigned to 60 , 75 , and 90 mg/m(2 ) , respectively . The hazard reductions from adding paclitaxel to CA were 17 % for recurrence ( adjusted Wald chi(2 ) P = .0023 ; unadjusted Wilcoxon P = .0011 ) and 18 % for death ( adjusted P = .0064 ; unadjusted P = .0098 ) . At 5 years , the disease-free survival ( + /- SE ) was 65 % ( + /- 1 ) and 70 % ( + /- 1 ) , and overall survival was 77 % ( + /- 1 ) and 80 % ( + /- 1 ) after CA alone or CA plus paclitaxel , respectively . The effects of adding paclitaxel were not significantly different in subsets defined by the protocol , but in an unplanned subset analysis , the hazard ratio of CA plus paclitaxel versus CA alone was 0.72 ( 95 % confidence interval , 0.59 to 0.86 ) for those with estrogen receptor-negative tumors and only 0.91 ( 95 % confidence interval , 0.78 to 1.07 ) for patients with estrogen receptor-positive tumors , almost all of whom received adjuvant tamoxifen . The additional toxicity from adding four cycles of paclitaxel was generally modest . CONCLUSION The addition of four cycles of paclitaxel after the completion of a st and ard course of CA improves the disease-free and overall survival of patients with early breast cancer PURPOSE We conducted an open-label , r and omized trial to determine whether ICRF-187 would reduce doxorubicin-induced cardiotoxicity in pediatric sarcoma patients . METHODS Thirty-eight patients were r and omized to receive doxorubicin-containing chemotherapy ( given as an intravenous bolus ) with or without ICRF-187 . Resting left ventricular ejection fraction ( LVEF ) was monitored serially with multigated radionuclide angiography ( MUGA ) scan . The two groups were compared for incidence and degree of cardiotoxicity , response rates to four cycles of chemotherapy , event-free and overall survival , and incidence and severity of noncardiac toxicities . RESULTS Eighteen ICRF-187-treated and 15 control patients were assessable for cardiac toxicity . ICRF-187-treated patients were less likely to develop sub clinical cardiotoxicity ( 22 % v 67 % , P < .01 ) , had a smaller decline in LVEF per 100 mg/m2 of doxorubicin ( 1.0 v 2.7 percentage points , P = .02 ) , and received a higher median cumulative dose of doxorubicin ( 410 v 310 mg/m2 , P < .05 ) than did control patients . Objective response rates were identical in the two groups , with no significant differences seen in event-free or overall survival . ICRF-187-treated patients had a significantly higher incidence of transient grade 1 serum transaminase elevations and a trend toward increased hematologic toxicity . CONCLUSION ICRF-187 reduces the risk of developing short-term sub clinical cardiotoxicity in pediatric sarcoma patients who receive up to 410 mg/m2 of doxorubicin . Response rates to chemotherapy , event-free and overall survival , and noncardiac toxicities appear to be unaffected by the use of ICRF-187 . Additional clinical trials with larger numbers of patients are needed to determine if the short-term cardioprotection afforded by ICRF-187 will reduce the incidence of late cardiac complications in long-term survivors of childhood cancer A phase II study utilizing VP-16 and adriamycin in a r and omized fashion tested the concept of synchronization of the drugs in treatment of metastatic breast cancer . Although there was a trend in median survival following the synchronized schedule , there was no significant difference in survival or progression-free intervals . The concept of synchronization was not established The Dana-Farber Cancer Institute ( DFCI ) acute lymphoblastic leukemia ( ALL ) Consortium Protocol 91 - 01 was design ed to improve the outcome of children with newly diagnosed ALL while minimizing toxicity . Compared with prior protocol s , post-remission therapy was intensified by substituting dexamethasone for prednisone and prolonging the asparaginase intensification from 20 to 30 weeks . Between 1991 and 1995 , 377 patients ( age , 0 - 18 years ) were enrolled ; 137 patients were considered st and ard risk ( SR ) , and 240 patients were high risk ( HR ) . Following a 5.0-year median follow-up , the estimated 5-year event-free survival ( EFS ) + /- SE for all patients was 83 % + /- 2 % , which is superior to prior DFCI ALL Consortium protocol s conducted between 1981 and 1991 ( P = .03 ) . There was no significant difference in 5-year EFS based upon risk group ( 87 % + /- 3 % for SR and 81 % + /- 3 % for HR , P = .24 ) . Age at diagnosis was a statistically significant prognostic factor ( P = .03 ) , with inferior outcomes observed in infants and children 9 years or older . Patients who tolerated 25 or fewer weeks of asparaginase had a significantly worse outcome than those who received at least 26 weeks of asparaginase ( P < .01 , both univariate and multivariate ) . Older children ( at least 9 years of age ) were significantly more likely to have tolerated 25 or fewer weeks of asparaginase ( P < .01 ) . Treatment on Protocol 91 - 01 significantly improved the outcome of children with ALL , perhaps due to the prolonged asparaginase intensification and /or the use of dexamethasone . The inferior outcome of older children may be due , in part , to increased intolerance of intensive therapy A prospect i ve r and omized trial was conducted to compare the cardiotoxic and therapeutic effects of doxorubicin ( 60 mg/m2 every 3 to 4 weeks ) administered by bolus or 72‐hour continuous infusion as adjuvant chemotherapy in 82 eligible patients after resection of high‐ grade soft tissue sarcoma of the extremity or superficial trunk . Cardiac toxicity , defined as a 10 % or greater decrease in left ventricular ejection fraction as assessed by radionuclide cineangiography , was evaluated in 69 patients . Cardiotoxicity was seen in 61 % of patients in the bolus treatment arm with the median doxorubicin dose of 420 mg/m2 . Among patients who received continuous infusion , 42 % had cardiotoxicity with a median dose of 540 mg/m2 . The rate of cardiotoxicity as a function of the cumulative dose of doxorubicin was significantly higher in the bolus treatment arm ( P = 0.0017 ) . Two patients in each group had clinical congestive heart failure , with one cardiac death occurring in each . There was a trend toward a lower rate of metastasis ( P = 0.19 ) and a significantly lower rate of death of disease ( P = 0.036 ) for patients treated with the bolus dose . Cox model analysis identified three unfavorable characteristics for the rate of developing a distant metastasis : blood transfusion within 24 hours of operation ( P < 0.00001 ) , tumor deep to the fascia and 5 cm or more in size ( P = 0.0043 ) , and a histologic subtype other than liposarcoma ( P = 0.0002 ) . The unfavorable effect of continuous infusion was not selected in the model ( P = 0.16 ) . Adjuvant chemotherapy for patients with soft tissue sarcoma is investigational . Furthermore , the impact of perioperative blood transfusion merits further study Forty-eight patients with advanced breast carcinoma who had not received prior chemotherapy ( minimum follow up 21 months ) were r and omised to receive either adriamycin 70 mg m-2 i.v . 3-weekly for 8 cycles ( Regimen A ) or adriamycin 35 mg m-2 i.v . 3-weekly for 16 courses ( Regimen B ) . Objective responses were seen in 14/24 ( 58 % ) patients with regimen A ( 4 complete ) and 6/24 ( 25 % ) with regimen B ( 1 complete ) ( P less than 0.02 ) . The median duration of response was 14 months with regimen A and 6.5 months with regimen B. The median duration of survival was 20 months and 8 months respectively ( P less than 0.01 ) . The toxicity was similar with each regimen . There was no evidence of deterioration in left ventricular ejection fraction nor congestive heart failure in any patient . It is concluded that when given at 3-weekly intervals adriamycin is a more effective treatment for advanced breast cancer at higher rather than lower dosage The activity and toxicity of single-agent st and ard-dose doxorubicin were compared with that of two schedules of high-dose epirubicin . A total of 334 chemonaive patients with histologically confirmed advanced soft-tissue sarcomas received ( A ) doxorubicin 75 mg m(-2 ) on day 1 ( 112 patients ) , ( B ) epirubicin 150 mg m(-2 ) on day 1 ( 111 patients ) or ( C ) epirubicin 50 mg m(-2 ) day(-1 ) on days 1 , 2 and 3 ( 111 patients ) ; all given as bolus injection at 3-week intervals . A median of four treatment cycles was given . Median age was 52 years ( 19 - 70 years ) and performance score 1 ( 0 - 2 ) . Of 314 evaluable patients , 45 ( 14 % ) had an objective tumour response ( eight complete response , 35 partial response ) . There were no differences among the three groups . Median time to progression for groups A , B and C was 16 , 14 and 12 weeks , and median survival 45 , 47 and 45 weeks respectively . Neither progression-free ( P = 0.93 ) nor overall survival ( P = 0.89 ) differed among the three groups . After the first cycle of therapy , two patients died of infection and one owing to cardiovascular disease , all on epirubicin . Both dose schedules of epirubicin were more myelotoxic than doxorubicin . Cardiotoxicity ( > or = grade 3 ) occurred in 1 % , 0 Output:	AUTHORS ' CONCLUSIONS An anthracycline infusion duration of six hours or longer reduces the risk of clinical heart failure and it seems to reduce the risk of sub clinical cardiac damage . No significant difference in the occurrence of clinical heart failure was identified in patients treated with a doxorubicin peak dose of less than 60 mg/m(2 ) or 60 mg/m(2 ) or more . For the other identified peak doses only one RCT was available , so no definitive conclusions can be made about the occurrence of cardiotoxicity .
MS2684	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Title Turnover intention in new graduate nurses : a multivariate analysis Aim This paper is a report of a study to determine the relationship of new nurse turnover intent with individual characteristics , work environment variables and organizational factors and to compare new nurse turnover with actual turnover in the 18 months of employment following completion of a residency . Background Because of their influence on patient safety and health outcomes nurse turnover and turnover intent have received considerable attention worldwide . When nurse staffing is inadequate , especially during nursing shortages , unfavourable clinical outcomes have been documented . Method Prospect i ve data collection took place from 1999 to 2006 with 889 new paediatric nurses who completed the same residency . Scores on study instruments were related to likelihood of turnover intent using logistic regression analysis models . Relationships between turnover intent and actual turnover were compared using Kaplan – Meier survivorship . Results The final model demonstrated that older respondents were more likely to have turnover intent if they did not get their ward choice . Also higher scores on work environment and organizational characteristics contributed to likelihood that the new nurse would not be in the turnover intent group . These factors distinguish a new nurse with turnover intent from one without 79 % of the time . Increased seeking of social support was related to turnover intent and older new graduates were more likely to be in the turnover intent group if they did not get their ward choice . Conclusion When new graduate nurses are satisfied with their jobs and pay and feel committed to the organization , the odds against turnover intent decrease . What is already known about this topic There is concern in many countries about nurse turnover and the result ing effects on patient safety and quality of care . Decreasing ability to recruit experienced nurses has increased the emphasis on recruitment of new graduate nurses , particularly in the United States of America . Historically , new graduate nurses have a high turnover rate within the first year of employment . What this paper adds When new graduate nurses are satisfied with their jobs and pay and feel committed to the organization , the odds of turnover intent decrease . Increased seeking social support to cope with the transition from student to competent Registered Nurse is related to turnover intent . Older graduates ( > 30 ) are 4·5 times more likely to have turnover intent if they do not get their ward of choice Purpose : Although simulation technology in nursing education is becoming increasingly commonplace , a review of the literature reveals a paucity of rigorous , high-level research comparing the effectiveness of simulation with other traditional education methods in the acquisition of clinical knowledge and skills . This research aim ed to investigate the impact of three learning interventions on graduate nurse health assessment knowledge and skills . It was hypothesized that the patient assessment skills of graduate nurses who completed a simulation learning activity would be superior to those who completed traditional education activities . Methods : Graduate nurses ( n = 74 ) were r and omly allocated to three groups ( 1 : self-directed learning package [ SDLP ] only ; 2 : SDLP plus two scenario-based PowerPoint workshops ; and 3 : SDLP plus two simulation education sessions using a manikin with low-fidelity capabilities . Following the education activities , graduates completed an individual test involving a systematic patient assessment upon a manikin . They were scored using a checklist of relevant responses . Results : Analysis of variance results suggest that the mean test score for nurses in the simulation group ( mean = 135.52 , SD = 26.63 ) was significantly higher ( P < 0.001 ) than those in the learning package group ( mean = 107.42 , SD = 29.82 ) and the PowerPoint group ( mean = 102.77 , SD = 31.68 ) . Conclusions : Simulation appears to be an effective educational tool for teaching patient assessment knowledge and skills to graduate nurses . Incorporation of such technology into graduate nurse education may decrease the time required to become clinical ly proficient , result ing in more confident and work-ready practitioners Rapid turnover of novice nurses eventually results in a shortage of veteran nurses . This study aim ed to clarify the factors affecting rapid turnover of novice nurses in a prospect i ve manner . We carried out an investigation in 20 university hospitals whose directors of nursing service departments accepted our request to cooperate with our research program . These hospitals were selected from all of the 102 university hospitals listed in The Hospital Catalog of Japan . The subjects were 1,203 novice hospital nurses who gave their informed consent for participation in our study . The question naires , which dealt with burnout , assertiveness , stressful life events , reality shock , ward assignment preference , transfer preference , job satisfaction ( workplace , salary , workload , and overtime ) , social support and coping mechanisms were completed by 923 novice nurses in June 2003 . Then , their turnover was investigated in December 2003 . Thirty-seven novice nurses ( 4.0 % ) quit during this period . Multiple logistic regression analysis showed that the factors affecting rapid turnover were 1 ) graduation from vocational nursing schools , 2 ) dissatisfaction with assignment to a ward contrary to their desire , and 3 ) no peers for support . Assignment of novice nurses to wards they choose as far as possible , avoidance of assigning novice nurses to wards alone , and establishment of a support system for nurses who graduate from vocational nursing schools seem to be important for preventing rapid turnover of novice nurses Specialised support for student nurses making the transition to graduate nurse can be crucial to successful and smooth adjustment , and can create a path to positive and stable career experiences . This paper describes an enhanced model of final year nursing student placements which was trialled in 2006 at the Queensl and University of Technology . The model involved collaboration with two major urban health services and re sources were developed to support effective transition experiences . Ninety-two students , including 29 trial participants and 63 non-trial participants were assessed on preparedness for professional practice , before and after the trial semester . Results indicated an increase in preparedness across the entire sample , but students participating in the trial did not differ significantly in overall preparedness change from those who did not participate . Higher baseline preparedness in the trial group highlighted the possibility that proactive students who choose enrichment experiences tend to be likelier to gain benefit from such options than those who do not . Qualitative findings from focus groups conducted with 12 transition group students highlighted that one of the main beneficial aspects of the experience for students was the sense of belonging to a team that understood their learning needs and could work constructively with them Abstract The transition from student to an accountable health professional is a difficult time for the novice nurse and can result in significant anxiety , stress and poor socialisation into the nursing profession . A strategy applied at a major tertiary teaching hospital to address transitional issues for novice nurses is that of group debriefing sessions . This qualitative study used focus groups to explore the effectiveness of these debriefing sessions for new graduate nurses and trainee enrolled nurses . The results demonstrated that the sessions provided nurses with a supportive environment , access to peer support and a sense of belonging . This provided an opportunity to develop confidence in their nursing competence and improvement in interpersonal communication skills . Debriefing sessions are an effective psychosocial support mechanism that can ameliorate the ‘ reality shock ’ experienced by nurses in their first year of practice . Group debriefing is an important component in the transitional support process and should be used to complement other strategies to enhance the psychosocial experiences of novice nurses Objective In an effort to better underst and turnover rates in hospitals and the effect of new nurses on them , this study sought to describe the characteristics and attitudes toward work of newly licensed RNs , a population important to both the nursing profession and the health care system . Methods A survey was mailed to a r and om sample of new RNs in 35 states and the District of Columbia . A total of 3,266 returned surveys met the inclusion criteria , for a response rate of 56 % . RNs who qualified had completed the licensing examination and obtained a first license between August 1 , 2004 , and July 31 , 2005 . Data pertaining to four areas were collected : respondent characteristics , work- setting characteristics , respondents ' attitudes toward work , and job opportunities . Respondents who were not working were asked to specify why . Results Of the eligible newly licensed RNs , 58.1 % had an associate 's degree , 37.6 % had a bachelor 's degree , and 4.3 % had a diploma or a master 's or higher degree as their first professional degree . They were generally pleased with their work groups but felt they had only moderate support from supervisors . About 13 % had changed principal jobs after one year , and 37 % reported that they felt ready to change jobs . More than half of the respondents ( 51 % ) worked voluntary overtime , and almost 13 % worked m and atory overtime . Also , 25 % reported at least one on-the-job needlestick in a year ; 39 % , at least one strain or sprain ; 21 % , a cut or laceration ; and 46 % , a bruise or contusion ; 62 % reported experiencing verbal abuse . A quarter of them found it “ difficult or impossible ” to do their jobs at least once per week because of inadequate supplies . Conclusions This study provides descriptive evidence that a majority of newly licensed RNs are reasonably satisfied and have no plans to change jobs , but the group is not homogeneous . The negative attitudes expressed in response to some survey questions suggest that newly licensed RNs may not remain in the acute care setting s where they start out . Investing in better orientation and management may be the key to retaining them in hospitals . The authors will be following these RNs for two years and will develop predictive models of turnover rates ProblemNew nurse graduates experience a stressful role transition into healthcare organizations , with 30 % leaving their first job within 1 year and 57 % leaving by 2 years of employment . Aim This study tests whether an internship program , Social and Professional Reality Integration for Nurse Graduates ( SPRING ) , improves new nurse graduate retention , sense of belonging , organizational commitment , and anticipated turnover . Design Quasi-experimental , posttest only , control group design . Method New nurse graduates hired by an academic institution that completed SPRING were compared with baseline nurse graduates who did not complete SPRING , using the Organizational Commitment Question naire , Modified Hagerty-Patusky Sense of Belonging Instrument , and Anticipated Turnover Scale . Retention was also examined . Results Anticipated Turnover was higher for baseline nurses than for 6-month SPRING nurses . Six-month SPRING nurses have lower antecedent sense of belonging than baseline or 12-month SPRING nurses . One-year retention is higher for SPRING new graduates than for non-SPRING new graduates . Conclusion Internship programs for nurse graduates must support the socialization of nurses and their transition into the professional role as well as teach the skills and knowledge needed for competence . This study supports the value of a comprehensive program for new nurse graduates in improving nurse retention and decreasing new nurse graduate intent to leave the organization at 6 months This is the third and final part of a series of articles that report the findings of a study that investigated the effects of a summer externship program on the transition into a professional role among nurses who participated in a summer nurse externship program at an acute care pediatric hospital . Specifically , this article reports the retention and recruitment benefits of a summer nurse externship program for the institution from 1998 through 2003 . A total of 153 externs out of the 193 ( 79.0 % ) assumed a registered nurse position at the institution , and 77 % remained in that role for 12 months . Overall , the nurse extern program for this institution appeared to be an effective recruitment and retention strategy that is on par with the institution and national data for retention and turnover data BACKGROUND Research regarding the relationship between preceptorship and development of critical thinking in new graduate nurses is sparse . No studies could be found that examined the relationship of preceptor education to critical thinking scores of new graduate nurses . METHODS A quasi-experimental , mixed- methods design measured critical thinking ability of new graduate nurses . Focus group interviews were conducted with preceptors who attended an author-developed educational program . RESULTS Preceptors ' participation in the educational session contributed to the evaluation subscale of critical thinking skills of the experimental group on the California Critical Thinking Skills Test ( F = 4.709 , p = .039 ) . Preceptors had positive qualitative responses . CONCLUSIONS Critical thinking skills of new graduate nurses can be improved and learning relationships developed through preceptor education . Further study is suggested Output:	The evidence suggests that transition interventions /strategies do lead to improvements in confidence and competence , job satisfaction , critical thinking and reductions in stress and anxiety for the newly qualified nurse . CONCLUSIONS This systematic review demonstrates the beneficial effects of transitional support strategies for newly qualified nurses from the perspective of the new nurse and their employer . The overall impact of support strategies appears positive , irrespective of the type of support provided . This may suggest that it is the organisations ' focus on new graduate nurses that is important , rather than simply leaving them to acclimatise to their new role themselves .
MS2685	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Pomalidomide and low-dose dexamethasone ( PomDex ) is st and ard treatment of lenalidomide refractory myeloma patients who have received > 2 prior therapies . We aim ed to assess the safety and efficacy of the addition of oral weekly cyclophosphamide to st and ard PomDex . We first performed a dose escalation phase 1 study to determine the recommended phase 2 dose of cyclophosphamide in combination with PomDex ( arm A ) . A r and omized , multicenter phase 2 study followed , enrolling patients with lenalidomide refractory myeloma . Patients were r and omized ( 1:1 ) to receive pomalidomide 4 mg on days 1 to 21 of a 28-day cycle in combination with weekly dexamethasone ( arm B ) or pomalidomide , dexamethasone , and cyclophosphamide ( PomCyDex ) 400 mg orally on days 1 , 8 , and 15 ( arm C ) . The primary end point was overall response rate ( ORR ) . Eighty patients were enrolled ( 10 in phase 1 and 70 r and omized in phase 2 : 36 to arm B and 34 to arm C ) . The ORR was 38.9 % ( 95 % confidence interval [ CI ] , 23 - 54.8 % ) and 64.7 % ( 95 % CI , 48.6 - 80.8 % ) for arms B and C , respectively ( P = .035 ) . As of June 2015 , 62 of the 70 r and omized patients had progressed . The median progression-free survival ( PFS ) was 4.4 ( 95 % CI , 2.3 - 5.7 ) and 9.5 months ( 95 % CI , 4.6 - 14 ) for arms B and C , respectively ( P = .106 ) . Toxicity was predominantly hematologic in nature but was not statistically higher in arm C. The combination of PomCyDex results in a superior ORR and PFS compared with PomDex in patients with lenalidomide refractory multiple myeloma . The trial was registered at www . clinical trials.gov as # NCT01432600 Bortezomib frequently produces severe treatment-related peripheral neuropathy ( PN ) in Waldenström 's macroglobulinemia ( WM ) . Carfilzomib is a neuropathy-sparing proteasome inhibitor . We examined carfilzomib , rituximab , and dexamethasone ( CaRD ) in symptomatic WM patients naïve to bortezomib and rituximab . Protocol therapy consisted of intravenous carfilzomib , 20 mg/m2 ( cycle 1 ) and 36 mg/m(2 ) ( cycles 2 - 6 ) , with intravenous dexamethasone , 20 mg , on days 1 , 2 , 8 , and 9 , and rituximab , 375 mg/m(2 ) , on days 2 and 9 every 21 days . Maintenance therapy followed 8 weeks later with intravenous carfilzomib , 36 mg/m(2 ) , and intravenous dexamethasone , 20 mg , on days 1 and 2 , and rituximab , 375 mg/m(2 ) , on day 2 every 8 weeks for 8 cycles . Overall response rate was 87.1 % ( 1 complete response , 10 very good partial responses , 10 partial responses , and 6 minimal responses ) and was not impacted by MYD88(L265P ) or CXCR4(WHIM ) mutation status . With a median follow-up of 15.4 months , 20 patients remain progression free . Grade ≥2 toxicities included asymptomatic hyperlipasemia ( 41.9 % ) , reversible neutropenia ( 12.9 % ) , and cardiomyopathy in 1 patient ( 3.2 % ) with multiple risk factors , and PN in 1 patient ( 3.2 % ) which was grade 2 . Declines in serum IgA and IgG were common . CaRD offers a neuropathy-sparing approach for proteasome inhibitor-based therapy in WM . This trial is registered at www . clinical trials.gov as # NCT01470196 BACKGROUND Few effective treatments exist for patients with refractory or relapsed and refractory multiple myeloma not responding to treatment with bortezomib and lenalidomide . Pomalidomide alone has shown limited efficacy in patients with relapsed multiple myeloma , but synergistic effects have been noted when combined with dexamethasone . We compared the efficacy and safety of pomalidomide plus low-dose dexamethasone with high-dose dexamethasone alone in these patients . METHODS This multicentre , open-label , r and omised phase 3 trial was undertaken in Australia , Canada , Europe , Russia , and the USA . Patients were eligible if they had been diagnosed with refractory or relapsed and refractory multiple myeloma , and had failed at least two previous treatments of bortezomib and lenalidomide . They were assigned in a 2:1 ratio with a vali date d interactive voice and internet response system to either 28 day cycles of pomalidomide ( 4 mg/day on days 1 - 21 , orally ) plus low-dose dexamethasone ( 40 mg/day on days 1 , 8 , 15 , and 22 , orally ) or high-dose dexamethasone ( 40 mg/day on days 1 - 4 , 9 - 12 , and 17 - 20 , orally ) until disease progression or unacceptable toxicity . Stratification factors were age ( ≤75 years vs > 75 years ) , disease population ( refractory vs relapsed and refractory vs bortezomib intolerant ) , and number of previous treatments ( two vs more than two ) . The primary endpoint was progression-free survival ( PFS ) . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT01311687 , and with EudraCT , number 2010 - 019820 - 30 . FINDINGS The accrual for the study has been completed and the analyses are presented . 302 patients were r and omly assigned to receive pomalidomide plus low-dose dexamethasone and 153 high-dose dexamethasone . After a median follow-up of 10·0 months ( IQR 7·2 - 13·2 ) , median PFS with pomalidomide plus low-dose dexamethasone was 4·0 months ( 95 % CI 3·6 - 4·7 ) versus 1·9 months ( 1·9 - 2·2 ) with high-dose dexamethasone ( hazard ratio 0·48 [ 95 % CI 0·39 - 0·60 ] ; p<0·0001 ) . The most common grade 3 - 4 haematological adverse events in the pomalidomide plus low-dose dexamethasone and high-dose dexamethasone groups were neutropenia ( 143 [ 48 % ] of 300 vs 24 [ 16 % ] of 150 , respectively ) , anaemia ( 99 [ 33 % ] vs 55 [ 37 % ] , respectively ) , and thrombocytopenia ( 67 [ 22 % ] vs 39 [ 26 % ] , respectively ) . Grade 3 - 4 non-haematological adverse events in the pomalidomide plus low-dose dexamethasone and high-dose dexamethasone groups included pneumonia ( 38 [ 13 % ] vs 12 [ 8 % ] , respectively ) , bone pain ( 21 [ 7 % ] vs seven [ 5 % ] , respectively ) , and fatigue ( 16 [ 5 % ] vs nine [ 6 % ] , respectively ) . There were 11 ( 4 % ) treatment-related adverse events leading to death in the pomalidomide plus low-dose dexamethasone group and seven ( 5 % ) in the high-dose dexamethasone group . INTERPRETATION Pomalidomide plus low-dose dexamethasone , an oral regimen , could be considered a new treatment option in patients with refractory or relapsed and refractory multiple myeloma . FUNDING Celgene Corporation The combination of pomalidomide and low-dose dexamethasone ( Pom-Dex ) can be safely administered to patients with end-stage relapsed/refractory multiple myeloma ( RRMM ) . However , we observed a shorter median progression-free survival ( PFS ) and overall survival ( OS ) in these patients when characterized with adverse cytogenetics ( deletion 17p and translocation [ 4;14 ] ) in the Intergroupe Francophone Myélome ( IFM ) 2009 - 02 trial . We then sought to determine whether MM with adverse cytogenetics would benefit more from Pom-Dex if exposed earlier in the multicenter IFM 2010 - 02 trial . The intention-to-treat population included 50 patients , with a median age of 63 years ( 38 % were ≥65 years ) . Interestingly , there was a striking difference in time to progression ( TTP ) , duration of response , and overall response rate ( ORR ) according to the presence of del(17p ) compared with t(4;14 ) ( TTP , 7.3 vs 2.8 months ; duration of response , 8.3 vs 2.4 months ; and ORR , 32 % vs 15 % ) . OS was prolonged after Pom-Dex , particularly in t(4;14 ) , given the short TTP , suggesting that patients were rescued at relapse with further lines of therapy . Pom-Dex , a doublet immunomodulatory drug-based regimen , is active and well tolerated in adverse cytogenetic patients with early RRMM , particularly in those with del(17p ) , who are characterized by a high and rapid development of a refractoriness state and known for their poor prognosis . Future studies will determine the underlying mechanisms of Pom-Dex activity in del(17p ) . This trial is registered at www . clinical trials.gov as # NCT01745640 This multicenter , open-label , r and omized phase 2 study assessed the efficacy and safety of pomalidomide ( POM ) with/without low-dose dexamethasone ( LoDEX ) in patients with relapsed/refractory multiple myeloma ( RRMM ) . Patients who had received ≥2 prior therapies ( including lenalidomide [ LEN ] and bortezomib [ BORT ] ) and had progressed within 60 days of their last therapy were r and omized to POM ( 4 mg/day on days 1 - 21 of each 28-day cycle ) with/without LoDEX ( 40 mg/week ) . The primary end point was progression-free survival ( PFS ) . In total , 221 patients ( median 5 prior therapies , range 1 - 13 ) received POM+LoDEX ( n = 113 ) or POM ( n = 108 ) . With a median follow-up of 14.2 months , median PFS was 4.2 and 2.7 months ( hazard ratio = 0.68 , P = .003 ) , overall response rates ( ORRs ) were 33 % and 18 % ( P = .013 ) , median response duration was 8.3 and 10.7 months , and median overall survival ( OS ) was 16.5 and 13.6 months , respectively . Refractoriness to LEN , or resistance to both LEN and BORT , did not affect outcomes with POM+LoDEX ( median PFS 3.8 months for both ; ORRs 30 % and 31 % ; and median OS 16 and 13.4 months ) . Grade 3 - 4 neutropenia occurred in 41 % ( POM+LoDEX ) and 48 % ( POM ) ; no grade 3 - 4 peripheral neuropathy was reported . POM+LoDEX was effective and generally well tolerated and provides an important new treatment option for RRMM patients who have received multiple prior therapies . This trial was registered at www . clinical trials.gov as # NCT00833833 The combination of pomalidomide and dexamethasone can be safely administered to patients with multiple myeloma ( MM ) and has significant efficacy , although the optimal regimen remains to be determined . Patients with MM whose disease progressed after multiple lines of therapy have limited treatment options . We design ed a multicenter , phase 2 r and omized study assessing two different dose regimens of pomalidomide and dexamethasone in advanced MM . Treatment response was assessed central ly . Pomalidomide ( 4 mg ) was given orally on days 1 to 21 ( arm 21/28 ) or continuously ( arm 28/28 ) over a 28-day cycle , plus dexamethasone given weekly . Eighty-four patients ( 43 , arm 21/28 and 41 , arm 28/28 ) were r and omized . The median number of prior lines was 5 . Overall response rate was 35 % ( arm 21/28 ) and 34 % ( arm 28/28 ) , independent of the number of prior lines and level of refractoriness . Median duration of response , time to Output:	Pomalidomide was generally well tolerated by patients reported in the studies .
MS2686	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Functional outcome , stability at radiographic investigation and ankle joint torque after anatomical reconstruction of the lateral ankle ligaments were evaluated in patients with early postoperative mobilization versus those with cast immobilization . Thirty patients with chronic lateral ligament instability of the ankle underwent anatomical reconstruction of the ligaments . Postoperatively the patients were r and omly allocated to two groups : Group A ( n=15 ) were immobilized in a below-knee plaster for 6 weeks and Group B ( n=15 ) underwent early controlled range of motion training using an Air-Cast ankle brace . The functional results were evaluated using a scoring scale and objective results using st and ardized stress radiographs . Also eccentric and concentric muscle torque at 60 degrees/s was measured in plantar flexion and dorsiflexion , respectively . The functional results were satisfactory in 12/15 ankles in Group A and 14/15 in Group B ( n.s . ) . All the patients with satisfactory results regained normal range of motion . Patients with unsatisfactory results had either residual pain or recurrent instability . In Group B , the strength measurements revealed significantly higher peak torque values after three months in plantar flexion at 60 degrees/s . Six months postoperatively , the torque values did not differ significantly between the groups . Also , there was no group difference in the laxity of the ankle joint , including both anterior talar translation test and talar tilt test , at the two-year follow-up . One patient had a superficial wound infection . We conclude that after the reconstruction of chronic lateral ligament instability of the ankle the functional and stability results were equally good with early postoperative mobilization and 6-week immobilization . However , using early mobilization plantar flexion strength was regained earlier than with cast immobilization , without any risk of short- or medium-term complications , such as increased ankle laxity . We recommend early mobilization after anatomical reconstruction of the lateral ankle ligaments To study the efficacy of an injury prevention program in a r and omized trial , 12 teams ( 180 players ) in a male senior soccer division were followed up for 6 months . The 12 teams were allocated at r and om to two groups of six teams , one being given a prophylactic program and the other serving as control . The program was based on previous studies of injury mechanisms . It comprised ( 1 ) correction of training , ( 2 ) provision of optimum equipment ; ( 3 ) prophylactic ankle taping ; ( 4 ) controlled rehabilitation ; ( 5 ) exclusion of players with grave knee instability ; ( 6 ) information about the impor tance of disciplined play and the increased risk of injury at training camps ; and ( 7 ) correction and supervision by doctor(s ) and physiotherapist(s ) . The injuries in the test teams were 75 % fewer than in the controls . The most common types of soccer injuries , sprains and strains to ankles and knees , were all significantly reduced . It is concluded that the pro posed prophylactic program , including close supervi sion and correction by doctors and physiotherapists , significantly reduces soccer injuries STUDY DESIGN Within-group repeated measures . OBJECTIVES To determine the effect of a semi-rigid prophylactic ankle stabilizer ( PAS ) on performance of subjects with post-acute , unilateral ankle sprains who have mechanically stable ankles , but are functionally impaired . BACKGROUND Most studies on PAS performance to date are limited to subjects with noninjured , nonimpaired ankles . No research has been reported to determine the effect PASs have on performance in subjects who have a mechanically stable , nonacute ankle sprain with functional impairment . METHODS AND MEASURES Twenty-five subjects ( 8 men and 17 women ; average height = 168.91 + /- 33.02 cm , average weight = 61.10 + /- 29.5 kg , and average age = 16.2 + /- 6 years ) met the qualification criteria of the study . Subjects had unilateral grade I or II lateral ankle sprains of 3 to 4 weeks duration and were cleared medically to return to activities of daily living . Each subject 's injured ankle was mechanically stable as determined by physical exam but was functionally impaired as determined by instability during the modified Rhomberg test . Separate 2 x 2 ANOVAs with repeated measures on brace condition ( Aircast SportStirrup and nonbraced control ) and test session ( test session 1 and test session 2 ) were completed to assess the effect of ankle stabilization on 2 dependent variables ( 36.58-m shuttle-run and vertical-jump ) . RESULTS Shuttle-run time was significantly faster for the braced condition ( mean = 9.43 + /- .72 seconds ) than for the nonbraced control ( mean = 9.57 + /- .75 seconds ) , regardless of test session . Shuttle-run time was significantly faster for test session 2 ( mean = 9.43 + /- .79 seconds ) than for test session 1 ( mean = 9.57 + /- .68 seconds ) , regardless of brace condition . No significant main or interaction effects occurred for vertical-jump . CONCLUSIONS Use of a semi-rigid PAS significantly increased shuttle-run but not vertical-jump performance . This effect was immediate and did not require PAS acclimation A bi-directional bicycle pedal that combines proprioceptive training and evertor strengthening has been developed for the treatment of residual instability after ankle sprains . A prospect i ve r and omized study was carried out on 19 subjects with recurrent ankle sprains and positive stress X-ray films . The subjects were r and omized to use either a bi-directional test pedal or a traditional uni-directional bicycle pedal and then completed a 6-week high-intensity training program on a cycle ergometer . Assessment of training intensity level was based on maximum oxygen uptake values , heart rate and lactate concentration in blood at various submaximal workloads . After completion of the training program , the subjects who had used the test pedal increased peak eversion torque at 180 degrees degrees s-1 by 14.2 % ( P = 0.020 ) , reduced figure-of-eight running time by 0.24 s ( P = 0.003 ) , improved single leg stance speed from 72.5 % to the maximum speed of 80 % ( P = 0.005 ) , and improved Karlsson functional score by 5.1 points ( P = 0.005 ) . In the control group , single leg stance improved from 56.1 to 67.8 % ( P = 0.018 ) , but otherwise no significant effects were found . This study indicates that short-term high-intensity training with a bi-directional pedal improves ankle performance and may be an option in the treatment of recurrent ankle sprains Early range of motion training after ligament reconstruction of the ankle ligaments for chronic ankle joint instability was evaluated . Forty patients were operated on with anatomic reconstruction of the lateral ankle ligaments , i.e. shortening , imbrication and reinsertion . The patients were r and omized postoperatively between two groups : ( 1 ) immobilization for 6 weeks in a plaster cast and ( 2 ) early range of motion training , in a Walker-Boot . Both groups underwent an identical rehabilitation program . with peroneal strengthening and co-ordination training after 6 weeks . The functional results were evaluated using a scoring scale and the mechanical stability with st and ardized stress radiographs . The minimum follow-up was 2 years . The functional results were satisfactory in 16 ( 80 % ) of the patients in group I , and 19 ( 95 % ) in group II . The mean values of anterior talar translation and talar tilt were not significantly different between the groups preoperatively nor at follow-up . The mean time period for sick leave was significantly shorter for group II , 6.5±1.6 weeks compared with 8.5±1.8 weeks for group I. The mean time period for return to sports activity was significantly shorter for group II , 9.5±2.2 weeks , compared with 12.5±2.6 weeks for group I. Early range of motion training is recommended after ligament reconstruction of the ankle , as it will enable earlier return to sports activities , shorter sick leave and preserved mechanical stability Objectives : To examine the effect of six weeks of strength and proprioception training on eversion to inversion isokinetic strength ratios ( E/I ratios ) in subjects with unilateral functional ankle instability . Methods : Thirty eight subjects were r and omly assigned to one of four treatment groups : strength training ( S ) ; proprioception training ( P ) ; strength + proprioception training ( B ) ; control ( C ) . Isokinetic strength was tested before and after training using a Kin Com 125 automatic positioning isokinetic dynamometer . Subtalar joint eversion and inversion motions were tested both concentrically and eccentrically through a range of motion involving 40 ° . All peak torque and average torque values were normalised for body mass . E/I ratios were calculated from average torque and peak torque measures by taking the concentric eversion value and combining it with the eccentric inversion value . Data were analysed using a mixed model analysis of variance with repeated measures on the test factor . Average torque and peak torque E/I ratios at 30 and 120 ° /s were analysed separately . Results : There were no significant differences in average torque and peak torque E/I ratios of the functionally unstable ankle for any of the groups after training compared with before . Conclusions : Six weeks of strength and proprioception training ( either alone or combined ) had no effect on isokinetic measures of strength in subjects with self reported unilateral functional instability . Further studies examining this agonist ( concentric ) to antagonist ( eccentric ) muscle group strength ratio are needed A study was undertaken to evaluate the effect of a semi rigid ankle orthosis ( Sport-Stirrup ) on the incidence of ankle sprains in soccer players during 1 playing season . Senior soccer players were divided into 2 groups : play ers with previous ankle sprains ( N = 258 ) and players without such history ( N = 246 ) . The players in these groups were each r and omly allocated to either a semi rigid orthosis or a control group at the start of the playing season . All subsequent injuries during the season and the total number of playing hours were documented . There was a significant reduction in the incidence of ankle sprains ( injuries/1 000 playing hours ) by ankles in the orthosis group with previous sprains ( 0.14 ) com pared with the nonbraced group with previous sprains ( 0.86 ) . The incidence of ankle sprains was significantly higher in the nonbraced group with previous sprains ( 0.86 ) compared with the nonbraced group without pre vious sprains ( 0.46 ) . Thus , in this study , a semirigid or thosis significantly reduced the incidence of recurrent ankle sprains in soccer players with previous history of ankle sprains Exercises to improve joint proprioception and coordination of the functionally unstable ankle are advocated throughout the literature , yet there is little evidence that these exercise have any effect on proprioception and balance . The purpose of this study was to determine the effects of a 6-week coordination and balance training program on proprioception of subjects with functional ankle instability . Forty-five subjects ( age = 22.53 + /- 3.95 years , height = 172.04 + /- 10.0 cm , weight = 71.72 + /- 15.7 kg ) were r and omly placed into a control ( Group 1 ) , sham ( Group 2 ) , or experimental ( Group 3 ) group . The experimental group trained 3 days per week , 10 minutes each day , performing various balance and proprioception exercises . Postural sway and active and passive joint position sense were assessed . Analysis of variance for postural sway modified equilibrium score for anterior and posterior sway , as well as medial and lateral sway revealed significant four-way interactions . Tukey post hoc analyses revealed that Group 3 performed significantly better ( p < .05 ) than Group 1 and Group 2 on the posttests . There were no significant differences for joint position sense or postural sway index . Results suggest that balance and coordination training can improve some measures of postural sway . It is still unclear if joint position sense can be improved in the functionally unstable ankle The present study investigated the effects of two different surgical procedures for the treatment of chronic ankle instability . Ten patients treated with an anatomic reconstruction using a periosteal f Output:	In view of the low quality methodology of almost all the studies , this review does not provide sufficient evidence to support any specific surgical or conservative intervention for chronic ankle instability . However , after surgical reconstruction , early functional rehabilitation was shown to be superior to six weeks immobilisation regarding time to return to work and sports
MS2687	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : Capacity to exercise may not be fully restored in patients with heart failure even in the long term after ventricular assist device ( VAD ) implantation . The benefits of exercise training in patients with VAD are unknown . Design and methods : Fifteen patients , aged 38.3 ± 15.9 years , bridged to heart transplantation with left ventricular assist device or biventricular assist device were r and omized at a ratio of 2 : 1 to a training group ( TG , n = 10 ) or a control group ( n = 5 ) , 6.3 ± 4 months after implantation . Both the groups were advised to walk 30–45 min/day . TG also underwent moderate-intensity aerobic exercise using a bike or treadmill for 45 min , three to five times a week , combined with high-intensity inspiratory muscle training using a computer- design ed software to respiratory exhaustion , two to three times a week for 10 weeks . The patients were tested using cardiopulmonary exercise testing , 6-min walk test , spirometry and electronic pressure manometer for inspiratory muscle strength ( Pimax ) and endurance ( sustained Pimax ) measurement . Quality of life was assessed with the Minnesota Living with Heart Failure question naire . Results : TG improved peak oxygen consumption ( 19.3 ± 4.5 vs. 16.8 ± 3.7 ml/kg per min , P = 0.008 ) and VO2 at ventilatory threshold ( 15.1 ± 4.2 vs. 12 ± 5.6 ml/kg per min , P = 0.01 ) , whereas the ventilation/carbon dioxide slope decreased ( 35.9 ± 5.6 vs. 40 ± 6.5 , P = 0.009 ) . The 6-min walk test distance increased ( 527 ± 76 vs. 462 ± 88 m , P = 0.005 ) and quality of life was improved ( 38.2 ± 11.6 vs. 48.9 ± 12.8 , P = 0.005 ) , as well as Pimax ( 131.8 ± 33 vs. 95.5 ± 28cmH2O , P = 0.005 ) , sustained Pimax ( 484 ± 195 vs. 340 ± 193cmH2O/s/10 3 , P = 0.005 ) , and inspiratoty lung capacity ( 2.4 ± 0.9 vs. 1.7 ± 0.7 L , P = 0.008 ) were improved . No significant changes were noted in the control group . Conclusion : Our findings indicate that exercise training may improve the functional status of VAD recipients even at a later period after implantation and thus , may have additional importance in cases of destination therapy PURPOSE Patients with chronic heart failure ( CHF ) report difficulty performing activities of daily living . To our knowledge , however , no study has directly measured performance in activities of daily living in these patients to systematic ally assess their level of physical disability . Moreover , the contribution of skeletal muscle weakness to physical disability in CHF remains unclear . Thus , we measured performance in activities of daily living in CHF patients and controls , its relationship to aerobic capacity and muscle strength , and the effect of resistance exercise training to improve muscle strength and physical disability . METHODS Patients and controls were assessed for performance in activities of daily living , self-reported physical function , peak aerobic capacity , body composition , and muscle strength before and after an 18-wk resistance training program . To remove the confounding effects of several disease-related factors ( muscle disuse , hospitalization , acute illness ) , we recruited controls with similar activity levels as CHF patients and tested patients > 6 months after any disease exacerbation/hospitalization . RESULTS Performance in activities of daily living was 30 % lower ( P < 0.05 ) in CHF patients versus controls and was related to both reduced aerobic capacity ( P < 0.001 ) and muscle strength ( P < 0.01 ) . Moreover , resistance training improved ( P < 0.05 to P < 0.001 ) physical function and muscle strength in patients and controls similarly , without altering aerobic capacity . CONCLUSIONS CHF patients are characterized by marked physical disability compared with age- and physical activity-matched controls , which is related to reduced aerobic capacity and muscle strength . CHF patients respond to resistance training with normal strength/functional adaptations . Our results support muscle weakness as a determinant of physical disability in CHF and show that interventions that increase muscle strength ( resistance training ) reduce physical disability CONTEXT Guidelines recommend that exercise training be considered for medically stable out patients with heart failure . Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes . OBJECTIVE To test the efficacy and safety of exercise training among patients with heart failure . DESIGN , SETTING , AND PATIENTS Multicenter , r and omized controlled trial of 2331 medically stable out patients with heart failure and reduced ejection fraction . Participants in Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ( HF-ACTION ) were r and omized from April 2003 through February 2007 at 82 centers within the United States , Canada , and France ; median follow-up was 30 months . INTERVENTIONS Usual care plus aerobic exercise training , consisting of 36 supervised sessions followed by home-based training , or usual care alone . MAIN OUTCOME MEASURES Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality , cardiovascular mortality or cardiovascular hospitalization , and cardiovascular mortality or heart failure hospitalization . RESULTS The median age was 59 years , 28 % were women , and 37 % had New York Heart Association class III or IV symptoms . Heart failure etiology was ischemic in 51 % , and median left ventricular ejection fraction was 25 % . Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12 . A total of 759 patients ( 65 % ) in the exercise training group died or were hospitalized compared with 796 patients ( 68 % ) in the usual care group ( hazard ratio [ HR ] , 0.93 [ 95 % confidence interval { CI } , 0.84 - 1.02 ] ; P = .13 ) . There were nonsignificant reductions in the exercise training group for mortality ( 189 patients [ 16 % ] in the exercise training group vs 198 patients [ 17 % ] in the usual care group ; HR , 0.96 [ 95 % CI , 0.79 - 1.17 ] ; P = .70 ) , cardiovascular mortality or cardiovascular hospitalization ( 632 [ 55 % ] in the exercise training group vs 677 [ 58 % ] in the usual care group ; HR , 0.92 [ 95 % CI , 0.83 - 1.03 ] ; P = .14 ) , and cardiovascular mortality or heart failure hospitalization ( 344 [ 30 % ] in the exercise training group vs 393 [ 34 % ] in the usual care group ; HR , 0.87 [ 95 % CI , 0.75 - 1.00 ] ; P = .06 ) . In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics , the HRs were 0.89 ( 95 % CI , 0.81 - 0.99 ; P = .03 ) for all-cause mortality or hospitalization , 0.91 ( 95 % CI , 0.82 - 1.01 ; P = .09 ) for cardiovascular mortality or cardiovascular hospitalization , and 0.85 ( 95 % CI , 0.74 - 0.99 ; P = .03 ) for cardiovascular mortality or heart failure hospitalization . Other adverse events were similar between the groups . CONCLUSIONS In the protocol -specified primary analysis , exercise training result ed in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points . After adjustment for highly prognostic predictors of the primary end point , exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00047437 OBJECTIVE Newer generation left ventricular assist devices ( LVADs ) are established for long-term support . The aim of this multi-modal intervention was to improve the body weight , exercise tolerance and psychosocial status in out patients on long-term LVAD support . METHODS Seventy patients participated in this non-r and omized intervention study [ intervention group ( IGr ) n = 34 ; control group ( CGr ) n = 36 ] over 18 months ( T1-T4 ) ; the baseline sample characteristics showed no differences between groups . Dietary counselling and weight management intervention was performed by a dietician based on a specific algorithm . Physical reconditioning followed a home ergometry protocol and was supplemented by psychosocial counselling . The outcomes were measured based on the body mass index ( BMI ) , cardiopulmonary exercise testing and self-report [ hospital anxiety and depression scale ( HADS ) , SF-36 ] . RESULTS The intervention showed a strong positive effect on nutrition and weight management [ 95 % confidence interval ( CI ) : -0.71 - 0.69 ; effect size ( ES ) : 0.907 ; P = 0.02 ) ] , result ing in the normal BMI ( kg/m(2 ) ) values in the IGr ( T1 : 24.0 ± 0.6 ; T4 : 24.5 ± 1.1 ; P = 0.35 ) compared with a significant BMI increase in the CGr ( T1 : 23.8 ± 0.6 ; T4 : 29.7 ± 0.8 ; P = 0.05 ) . Significant differences appeared regarding exercise tolerance ( VO(2)max/% predicted ) in favour of IGr patients ( IGr : 69 ± 2.9 ; CGr 62 ± 3.7 ; P = 0.04 ) . This increase was reflected by patients ' self-reporting based on the SF-36 physical component score ( IGr : P = 0.04 ; CGr : P = 0.54 ) . SF-36 psychosocial component scores showed no changes for both groups . However , CGr showed a tendency for increased anxiety scores relative to their counterparts ( IGr : 4.95 ± 0.4 ; CGr : 6.6 ± 0.9 ; P = 0.03 ) . CONCLUSIONS IGr patients showed a strong benefit from a multi-modal intervention , including dietary counselling , controlled exercise and psychosocial support . Dietary counselling holds potential to prevent obesity in this patient population Twenty-five patients ( aged 62 + /- 2 years ) with stable , moderate to severe ischemic congestive heart failure ( CHF ) ( New York Heart Association class II/III : 15/10 ; ejection fraction 21.6 + /- 2 % ; and peak oxygen uptake 13.6 + /- 0.7 ml/kg/min ) were studied to evaluate the ability of different methods to characterize autonomic tone in chronic CHF . Sympathovagal balance was assessed by : ( 1 ) heart rate variability in the time domain , assessed by the SD of RR intervals ; ( 2 ) heart rate variability in the frequency domain , assessed by low- ( 0.03 to 0.14 Hz ) and high- ( 0.18 to 0.40 Hz ) frequency components of heart rate variability by autoregressive power spectral analysis ; ( 3 ) 24-hour , daytime and nighttime heart rate ; ( 4 ) submaximal heart rate during upright bicycle exercise , with respiratory gas analysis to obtain peak oxygen uptake ; and ( 5 ) radiolabeled norepinephrine spillover . These methods did not correlate , with the exception of day and nighttime heart rate ( r = 0.74 ; p < 0.001 ) and the expected inverse correlation between low and high frequency ( r = -0.92 ; p < 0.001 ) . No method correlated significantly with peak oxygen uptake , exercise tolerance or ejection fraction . After 8 weeks of physical training at home , all methods showed improvement in autonomic balance : increases in SD of RR intervals ( + 21 % ; p < 0.02 ) and high frequency ( + 41 % ; p < 0.007 ) , and decreases in low frequency ( -19 % ; p < 0.002 ) , low-/high-frequency ratio ( -48 % ; p < 0.03 ) , norepinephrine spillover ( -28.9 % ; p < 0.03 ) , 24-hour heart rate ( -2.7 % ; p < 0.005 ) and submaximal heart rate ( -10.8 % ; p < 0.01 ) . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy . New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices . METHODS In this r and omized trial , we enrolled patients with advanced heart failure who were ineligible for transplantation , in a 2: Output:	Our systematic review suggests supervised ET has an inconsistent effect on exercise capacity and QoL when compared to control groups undergoing usual care . These results suggest that supervised ET is safe and can improve patient outcomes in LVAD patients when compared to the usual care
MS2688	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background —Interruptions to chest compression – generated blood flow during cardiopulmonary resuscitation ( CPR ) are detrimental . Data show that such interruptions for mouth-to-mouth ventilation require a period of “ rebuilding ” of coronary perfusion pressure to obtain the level achieved before the interruption . Whether such hemodynamic compromise from pausing to ventilate is enough to affect outcome is unknown . Methods and Results —Thirty swine ( weight 35±2 kg ) underwent 3 minutes of untreated ventricular fibrillation before 12 minutes of basic life support CPR . Animals were r and omized to receive either st and ard airway ( A ) , breathing ( B ) , and compression ( C ) CPR with expired-gas ventilation in a 15:2 compression-to-ventilation ratio or continuous chest compression CPR . Those r and omized to the st and ard 15:2 group had no chest compressions for a period of 16 seconds each time the 2 ventilations were delivered . Defibrillation was attempted at 15 minutes of cardiac arrest . All resuscitated animals were supported in an intensive care environment for 1 hour , then in a maintenance facility for 24 hours . The primary end point of neurologically normal 24-hour survival was significantly better in the experimental group receiving continuous chest compression CPR ( 12 of 15 versus 2 of 15;P < 0.0001 ) . Conclusions —Mouth-to-mouth ventilation performed by single layperson rescuers produces substantial interruptions in chest compression – supported circulation . Continuous chest compression CPR produces greater neurologically normal 24-hour survival than st and ard ABC CPR when performed in a clinical ly realistic fashion . Any technique that minimizes lengthy interruptions of chest compressions during the first 10 to 15 minutes of basic life support should be given serious consideration in future efforts to improve outcome results from cardiac arrest CONTEXT The survival benefit of well-performed cardiopulmonary resuscitation ( CPR ) is well-documented , but little objective data exist regarding actual CPR quality during cardiac arrest . Recent studies have challenged the notion that CPR is uniformly performed according to established international guidelines . OBJECTIVES To measure multiple parameters of in-hospital CPR quality and to determine compliance with published American Heart Association and international guidelines . DESIGN AND SETTING A prospect i ve observational study of 67 patients who experienced in-hospital cardiac arrest at the University of Chicago Hospitals , Chicago , Ill , between December 11 , 2002 , and April 5 , 2004 . Using a monitor/defibrillator with novel additional sensing capabilities , the parameters of CPR quality including chest compression rate , compression depth , ventilation rate , and the fraction of arrest time without chest compressions ( no-flow fraction ) were recorded . MAIN OUTCOME MEASURE Adherence to American Heart Association and international CPR guidelines . RESULTS Analysis of the first 5 minutes of each resuscitation by 30-second segments revealed that chest compression rates were less than 90/min in 28.1 % of segments . Compression depth was too shallow ( defined as < 38 mm ) for 37.4 % of compressions . Ventilation rates were high , with 60.9 % of segments containing a rate of more than 20/min . Additionally , the mean ( SD ) no-flow fraction was 0.24 ( 0.18 ) . A 10-second pause each minute of arrest would yield a no-flow fraction of 0.17 . A total of 27 patients ( 40.3 % ) achieved return of spontaneous circulation and 7 ( 10.4 % ) were discharged from the hospital . CONCLUSIONS In this study of in-hospital cardiac arrest , the quality of multiple parameters of CPR was inconsistent and often did not meet published guideline recommendations , even when performed by well-trained hospital staff . The importance of high- quality CPR suggests the need for rescuer feedback and monitoring of CPR quality during resuscitation efforts IMPORTANCE A strategy using mechanical chest compressions might improve the poor outcome in out-of-hospital cardiac arrest , but such a strategy has not been tested in large clinical trials . OBJECTIVE To determine whether administering mechanical chest compressions with defibrillation during ongoing compressions ( mechanical CPR ) , compared with manual cardiopulmonary resuscitation ( manual CPR ) , according to guidelines , would improve 4-hour survival . DESIGN , SETTING , AND PARTICIPANTS Multicenter r and omized clinical trial of 2589 patients with out-of-hospital cardiac arrest conducted between January 2008 and February 2013 in 4 Swedish , 1 British , and 1 Dutch ambulance services and their referring hospitals . Duration of follow-up was 6 months . INTERVENTIONS Patients were r and omized to receive either mechanical chest compressions ( LUCAS Chest Compression System , Physio-Control/Jolife AB ) combined with defibrillation during ongoing compressions ( n = 1300 ) or to manual CPR according to guidelines ( n = 1289 ) . MAIN OUTCOMES AND MEASURES Four-hour survival , with secondary end points of survival up to 6 months with good neurological outcome using the Cerebral Performance Category ( CPC ) score . A CPC score of 1 or 2 was classified as a good outcome . RESULTS Four-hour survival was achieved in 307 patients ( 23.6 % ) with mechanical CPR and 305 ( 23.7 % ) with manual CPR ( risk difference , -0.05 % ; 95 % CI , -3.3 % to 3.2 % ; P > .99 ) . Survival with a CPC score of 1 or 2 occurred in 98 ( 7.5 % ) vs 82 ( 6.4 % ) ( risk difference , 1.18 % ; 95 % CI , -0.78 % to 3.1 % ) at intensive care unit discharge , in 108 ( 8.3 % ) vs 100 ( 7.8 % ) ( risk difference , 0.55 % ; 95 % CI , -1.5 % to 2.6 % ) at hospital discharge , in 105 ( 8.1 % ) vs 94 ( 7.3 % ) ( risk difference , 0.78 % ; 95 % CI , -1.3 % to 2.8 % ) at 1 month , and in 110 ( 8.5 % ) vs 98 ( 7.6 % ) ( risk difference , 0.86 % ; 95 % CI , -1.2 % to 3.0 % ) at 6 months with mechanical CPR and manual CPR , respectively . Among patients surviving at 6 months , 99 % in the mechanical CPR group and 94 % in the manual CPR group had CPC scores of 1 or 2 . CONCLUSIONS AND RELEVANCE Among adults with out-of-hospital cardiac arrest , there was no significant difference in 4-hour survival between patients treated with the mechanical CPR algorithm or those treated with guideline -adherent manual CPR . The vast majority of survivors in both groups had good neurological outcomes by 6 months . In clinical practice , mechanical CPR using the presented algorithm did not result in improved effectiveness compared with manual CPR . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00609778 AIM Recently three large post product placement studies , comparing mechanical chest compression ( cc ) devices to those who received manual cc , found equivalent outcome results for both groups . Thus the question arises whether those results could be replicated using the devices on a daily routine . METHODS We prospect ively enrolled 948 patients over a 12 months period . Chi-Square test and Mann-Whitney-U test were used to assess differences between " manual " and " mechanical " cc subgroups . Uni- and multivariate Cox regression hazard analysis were used to assess the influence of cc type on survival . RESULTS A mechanical cc device was used in 30.1 % ( n=283 ) cases . Patients who received mechanical cc had a significantly worse neurological outcome - measured in cerebral performance category ( CPC ) - than the manual cc group ( 56.8 % vs. 78.6 % , p=0.009 ) . Patients receiving mechanical cc were significantly younger , more were male and were more likely to have byst and er CPR and an initially shock-able ECG rhythm . There was no difference in the quality of CPR that might explain the worse outcome in mechanical cc patients . CONCLUSION Even with high quality CPR in both , manual and mechanical cc groups , outcome in patients who received mechanical cc was significantly worse . The anticipated benefits of a higher compression ratio and a steadier compression depth of a mechanical cc device remain uncertain . In this study selection for mechanical cc was not st and ardized , and was non-r and om . This merits further investigation . Further research on how mechanical cc is chosen and used should be considered . CLINICAL TRIAL REGISTRATION https://ekmeduniwien.at/core/catalog/2013/ ( EK-Nr:1221/2013 ) Background —Recent data highlight a vital link between well-performed cardiopulmonary resuscitation ( CPR ) and survival after cardiac arrest ; however , the quality of CPR as actually performed by trained healthcare providers is largely unknown . We sought to measure in-hospital chest compression rates and to determine compliance with published international guidelines . Methods and Results —We developed and vali date d a h and held recording device to measure chest compression rate as a surrogate for CPR quality . A prospect i ve observational study of adult cardiac arrests was performed at 3 hospitals from April 2002 to October 2003 . Resuscitations were witnessed by trained observers using a customized personal digital assistant programmed to store the exact time of each chest compression , allowing offline calculation of compression rates at serial time points . In 97 arrests , data from 813 minutes during which chest compressions were delivered were analyzed in 30-second time segments . In 36.9 % of the total number of segments , compression rates were < 80 compressions per minute ( cpm ) , and 21.7 % had rates < 70 cpm . Higher chest compression rates were significantly correlated with initial return of spontaneous circulation ( mean chest compression rates for initial survivors and nonsurvivors , 90±17 and 79±18 cpm , respectively ; P=0.0033 ) . Conclusions —In-hospital chest compression rates were below published resuscitation recommendations , and suboptimal compression rates in our study correlated with poor return of spontaneous circulation . CPR quality is likely a critical determinant of survival after cardiac arrest , suggesting the need for routine measurement , monitoring , and feedback systems during actual resuscitation CONTEXT Defibrillation as soon as possible is st and ard treatment for patients with ventricular fibrillation . A nonr and omized study indicates that after a few minutes of ventricular fibrillation , delaying defibrillation to give cardiopulmonary resuscitation ( CPR ) first might improve the outcome . OBJECTIVE To determine the effects of CPR before defibrillation on outcome in patients with ventricular fibrillation and with response times either up to or longer than 5 minutes . DESIGN , SETTING , AND PATIENTS R and omized trial of 200 patients with out-of-hospital ventricular fibrillation in Oslo , Norway , between June 1998 and May 2001 . Patients received either st and ard care with immediate defibrillation ( n = 96 ) or CPR first with 3 minutes of basic CPR by ambulance personnel prior to defibrillation ( n = 104 ) . If initial defibrillation was unsuccessful , the st and ard group received 1 minute of CPR before additional defibrillation attempts compared with 3 minutes in the CPR first group . MAIN OUTCOME MEASURE Primary end point was survival to hospital discharge . Secondary end points were hospital admission with return of spontaneous circulation ( ROSC ) , 1-year survival , and neurological outcome . A prespecified analysis examined subgroups with response times either up to or longer than 5 minutes . RESULTS In the st and ard group , 14 ( 15 % ) of 96 patients survived to hospital discharge vs 23 ( 22 % ) of 104 in the CPR first group ( P = .17 ) . There were no differences in ROSC rates between the st and ard group ( 56 % [ 58/104 ] ) and the CPR first group ( 46 % [ 44/96 ] ; P = .16 ) ; or in 1-year survival ( 20 % [ 21/104 ] and 15 % [ 14/96 ] , respectively ; P = .30 ) . In subgroup analysis for patients with ambulance response times of either up to 5 minutes or shorter , there were no differences in any outcome variables between the CPR first group ( n = 40 ) and the st and ard group ( n = 41 ) . For patients with response intervals of longer than 5 minutes , more patients achieved ROSC in the CPR first group ( 58 % [ 37/64 ] ) compared with the st and ard group ( 38 % [ 21/55 ] ; odds ratio [ OR ] , 2.22 ; 95 % confidence interval [ CI ] , 1.06 - 4.63 ; P = .04 ) ; survival to hospital discharge ( 22 % [ 14/64 ] vs 4 % [ 2/55 ] ; OR , 7.42 ; 95 % CI , 1.61 - 34.3 ; P = .006 ) ; and 1-year survival ( 20 % [ 13/64 ] vs 4 % [ 2/55 ] ; OR , 6.76 ; 95 % CI , 1.42 - 31.4 ; P = .01 ) . Thirty-three ( 89 % ) of 37 patients who survived to hospital dis Output:	However , the results were not statistically significant between different kinds of mechanical chest compression devices and manual resuscitation in survival to admission , discharge and CPC scores for OHCA patients and survival to discharge for in-hospital CA patients . Conclusions The ability to achieve ROSC with mechanical devise was inferior to manual chest compression during resuscitation . The use of mechanical chest compression can not be recommended as a replacement for manual CPR , but rather a supplemental treatment in an overall strategy for treating CA patients
MS2689	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study . An analysis including all subjects , with the last observation carried forward for those who dropped out , showed that subjects on the low-carbohydrate diet lost more weight than those on the low-fat diet ( mean [ + /-SD ] , -5.8+/-8.6 kg vs. -1.9+/-4.2 kg ; P=0.002 ) and had greater decreases in triglyceride levels ( mean , -20+/-43 percent vs. -4+/-31 percent ; P=0.001 ) , irrespective of the use or nonuse of hypoglycemic or lipid-lowering medications . Insulin sensitivity , measured only in subjects without diabetes , also improved more among subjects on the low-carbohydrate diet ( 6+/-9 percent vs. -3+/-8 percent , P=0.01 ) . The amount of weight lost ( P<0.001 ) and assignment to the low-carbohydrate diet ( P=0.01 ) were independent predictors of improvement in triglyceride levels and insulin sensitivity . CONCLUSIONS Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet , with a relative improvement in insulin sensitivity and triglyceride levels , even after adjustment for the amount of weight lost . This finding should be interpreted with caution , given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study . Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality BACKGROUND There is conflicting evidence on the benefits of foods rich in vitamin E ( alpha-tocopherol ) , n-3 polyunsaturated fatty acids ( PUFA ) , and their pharmacological substitutes . We investigated the effects of these substances as supplements in patients who had myocardial infa rct ion . METHODS From October , 1993 , to September , 1995 , 11,324 patients surviving recent ( < or = 3 months ) myocardial infa rct ion were r and omly assigned supplements of n-3 PUFA ( 1 g daily , n=2836 ) , vitamin E ( 300 mg daily , n=2830 ) , both ( n=2830 ) , or none ( control , n=2828 ) for 3.5 years . The primary combined efficacy endpoint was death , non-fatal myocardial infa rct ion , and stroke . Intention-to-treat analyses were done according to a factorial design ( two-way ) and by treatment group ( four-way ) . FINDINGS Treatment with n-3 PUFA , but not vitamin E , significantly lowered the risk of the primary endpoint ( relative-risk decrease 10 % [ 95 % CI 1 - 18 ] by two-way analysis , 15 % [ 2 - 26 ] by four-way analysis ) . Benefit was attributable to a decrease in the risk of death ( 14 % [ 3 - 24 ] two-way , 20 % [ 6 - 33 ] four-way ) and cardiovascular death ( 17 % [ 3 - 29 ] two-way , 30 % [ 13 - 44 ] four-way ) . The effect of the combined treatment was similar to that for n-3 PUFA for the primary endpoint ( 14 % [ 1 - 26 ] ) and for fatal events ( 20 % [ 5 - 33 ] ) . INTERPRETATION Dietary supplementation with n-3 PUFA led to a clinical ly important and statistically significant benefit . Vitamin E had no benefit . Its effects on fatal cardiovascular events require further exploration The effects of variations in dietary carbohydrate and fat on various aspects of carbohydrate and lipoprotein metabolism were evaluated in 10 healthy , postmenopausal women . The two diets were isoenergetic , assigned in r and om fashion , and consisted ( as a % of total energy ) of 15 % protein , 60 % carbohydrate , and 25 % fat ( 60%-carbohydrate diet ) or 15 % protein , 40 % carbohydrate , and 45 % fat ( 40%-carbohydrate diet ) . Fasting plasma triacylglycerol , very-low-density-lipoprotein ( VLDL ) triacylglycerol , and VLDL-cholesterol concentrations were higher ( P < 0.05 - 0.001 ) after the 60%-carbohydrate diet , whereas high-density-lipoprotein ( HDL ) cholesterol was lower ( P < 0.05 ) . Plasma insulin and triacylglycerol concentrations were also higher ( P < 0.001 ) from 0800 to 0000 with the 60%-carbohydrate diet than with the 40%-carbohydrate diet . In addition , when vitamin A was given with the noon meal , the ensuing concentrations of retinyl palmitate were also higher after ingestion of the 60%-carbohydrate diet . Resistance to insulin-mediated glucose disposal , quantified at baseline by determining the steady state plasma glucose ( SSPG ) concentration at the end of a 180-min infusion of somatostatin , insulin , and glucose , correlated with the incremental increases in postpr and ial concentrations of plasma glucose ( r = 0.68 , P = 0.06 ) , insulin ( r = 0.82 , P < 0.02 ) , triacylglycerol ( r = 0.77 , P < 0.05 ) , and retinyl palmitate ( r = 0.68 , P = 0.06 ) and with the Sf > 400 triacylglycerol ( r = 0.77 , P < 0.05 ) , Sf 20 - 400 triacylglycerol ( r = 0.72 , P < 0.05 ) , and Sf > 400 retinyl palmitate ( r = 0.75 , P < 0.01 ) lipoprotein fractions . Because all of these changes would increase risk of ischemic heart disease in postmenopausal women , it seems reasonable to question the wisdom of recommending that postmenopausal women consume low-fat , high-carbohydrate diets BACKGROUND Metabolic studies suggest that saturated fatty acids differ in their effects on blood lipids . OBJECTIVE The objective was to examine the associations between intakes of individual saturated fatty acids and their food sources in relation to the risk of coronary heart disease ( CHD ) . DESIGN This was a prospect i ve cohort study of 80082 women in the Nurses ' Health Study aged 34 - 59 y. Subjects had no known cardiovascular disease , cancer , hypercholesterolemia , or diabetes , and completed vali date d food-frequency question naires in 1980 . RESULTS During 14 y of follow-up , we documented 939 incident cases of major CHD events . In multivariate analyses in which age , smoking , and other covariates were controlled for , intakes of short- to medium-chain saturated fatty acids ( 4:0 - 10:0 ) were not significantly associated with the risk of CHD . In contrast , intakes of longer-chain saturated fatty acids ( 12:0 - 18:0 ) were each separately associated with a small increase in risk . The multivariate RR for a 1 % energy increase from stearic acid was 1.19 ( 95 % CI : 1.02 , 1.37 ) . The ratio of polyunsaturated to saturated fat was strongly and inversely associated with CHD risk ( multivariate RR for a comparison of the highest with the lowest deciles : 0.58 ; 95 % CI : 0.41 , 0.83 ; P for trend < 0.0001 ) . Conversely , higher ratios of red meat to poultry and fish consumption and of high-fat to low-fat dairy consumption were associated with significantly greater risk . CONCLUSION A distinction between stearic acid and other saturated fats does not appear to be important in dietary advice to reduce CHD risk , in part because of the high correlation between stearic acid and other saturated fatty acids in typical diets BACKGROUND Data on the relation between alpha-linolenic acid intake and coronary artery disease ( CAD ) are limited . Other dietary components appear to modify the reported relation between alpha-linolenic acid intake and CAD . OBJECTIVE We examined whether dietary alpha-linolenic acid intake was inversely associated with risk of CAD . DESIGN We prospect ively studied 667 men aged 64 - 84 y from the Zutphen Elderly Study who were free of CAD at baseline . Dietary intake was assessed by using a cross-check dietary history method . RESULTS During the 10-y follow-up , we documented 98 cases of CAD . After adjustment for age , st and ard coronary risk factors , and intake of trans fatty acids and other nutrients , alpha-linolenic acid intake was not significantly associated with CAD risk . The relative risk of CAD for the highest compared with the lowest tertile of alpha-linolenic acid intake was 1.68 ( 95 % CI : 0.86 , 3.29 ) . alpha-Linolenic acid intake from sources containing trans fatty acids was also nonsignificantly , yet positively , associated with CAD risk . alpha-Linolenic acid intake from foods that did not contain trans fatty acids was not associated with CAD risk , the relative risk of CAD for the highest compared with the lowest tertile was 1.15 ( 95 % CI : 0.63 , 2.11 ) . CONCLUSION We did not observe a beneficial effect of dietary alpha-linolenic acid intake on the risk of 10-y CAD incidence . Investigating this hypothesis was complicated by the association between intakes of alpha-linolenic acid and trans fatty acids . Given the results of current prospect i ve studies , a protective cardiac effect of alpha-linolenic acid is question able BACKGROUND Previous studies on diet and coronary heart disease ( CHD ) focused primarily on individual nutrients or foods . OBJECTIVE We examined whether overall dietary patterns derived from a food-frequency question naire ( FFQ ) predict risk of CHD in men . DESIGN This was a prospect i ve cohort study of 44875 men aged 40 - 75 y without diagnosed cardiovascular disease or cancer at baseline in 1986 . RESULTS During 8 y of follow-up , we documented 1089 cases of CHD ( nonfatal myocardial infa rct ion and fatal CHD ) . Using factor analysis , we identified 2 major dietary patterns using dietary data collected through a 131-item FFQ . The first factor , which we labeled the " prudent pattern , " was characterized by higher intake of vegetables , fruit , leg Output:	RESULTS Strong evidence supports valid associations ( 4 criteria satisfied ) of protective factors , including intake of vegetables , nuts , and " Mediterranean " and high- quality dietary patterns with CHD , and associations of harmful factors , including intake of trans-fatty acids and foods with a high glycemic index or load . Among studies of higher method ologic quality , there was also strong evidence for monounsaturated fatty acids and " prudent " and " western " dietary patterns . Insufficient evidence ( < or = 2 criteria ) of association is present for intake of supplementary vitamin E and ascorbic acid ( vitamin C ) ; saturated and polyunsaturated fatty acids ; total fat ; alpha-linolenic acid ; meat ; eggs ; and milk . Among the dietary exposures with strong evidence of causation from cohort studies , only a Mediterranean dietary pattern is related to CHD in r and omized trials . The evidence supports a valid association of a limited number of dietary factors and dietary patterns with CHD .
MS2690	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Fourteen intubated infants recovering from neonatal respiratory disease had arterial blood gases and lung mechanics measured in the supine position and in two variants of the prone position . Prone positioning result ed in significant increases in mean ( + /- SEM ) arterial oxygen tension ( Pa(o2 70.4 + /- 2.5 to 81.1 + /- 4.4 mm Hg ) , dynamic lung compliance ( 1.7 + /- 0.24 to 2.55 + /- 0.37 ml/cm H2O ) , and tidal volume ( 8.6 + /- 1.0 to 10.5 + /- 1.2 ml ) when all prone values were compared to supine values . Prone positioning with the abdomen protruding freely , when compared to all supine values , was associated with significantly increased dynamic lung compliance and tidal volume . Values for prone-abdomen free were not significantly different from values for prone-abdomen restricted . This suggests that there are clinical benefits from prone positioning in neonates recovering from respiratory disease Our objective was to determine the effect of posture on respiratory function and drive in prematurely born infants immediately prior to discharge . Twenty infants ( 6 oxygen-dependent ) , median gestational age 29 weeks ( range , 25 - 32 ) , were studied at a median postconceptional age ( PCA ) of 36 weeks ( range , 33 - 39 ) . On 2 successive days , infants were studied both supine and prone ; each posture was maintained for 3 hr . The order on each day in which postures were studied was r and omized between infants . At the end of each 3-hr period , tidal volume ( Vt ) , inspiratory ( Ti ) and expiratory ( Te ) time , respiratory rate , and minute ventilation were measured . In addition , respiratory drive was assessed by measuring the pressure generated in the first 100 msec of an imposed airway occlusion ( P(0.1 ) ) , and respiratory muscle strength was assessed by recording the maximum inspiratory pressure ( Pimax ) generated against an occlusion which was maintained for at least five breaths . Overall , tidal volume was higher ( P < 0.05 ) , but respiratory rate ( P < 0.05 ) , P(0.1 ) ( P < 0.05 ) , and Pimax ( P < 0.05 ) were lower in the prone compared to the supine position . There were no significant differences in Ti or Te between the two postures . In oxygen-dependent infants only , minute volume was higher in the prone position ( P < 0.05 ) . In conclusion , posture-related differences in respiratory function are present in prematurely born infants studied prior to neonatal unit discharge Studies of the effect of body position during and after bolus feeding upon gastric emptying or gastric residual have not had consistent results . We tested the hypotheses that right lateral decubitus leads to less gastric residual than left lateral decubitus and that the prone position leads to less gastric residual than the supine position . A prospect i ve r and omized clinical trial with triple crossover of healthy growing , appropriate for gestational age preterm infants . Each infant was successively studied while fed in the four different positions . Gastric residuals were measured at 1 and 3 hours after initiation of feeding and returned . Thirty-one patients were studied . At 1 hour , right lateral decubitus led to less significant residuals than the left lateral decubitus and the prone position led to less residual than the left lateral decubitus . The amount of gastric residuals 1 hour after a meal appears to be in the following decreasing order : left , supine , prone , right UNLABELLED BACKGROUND . The preterm infant is subject to the force of gravity : when its body lies pressed against the mattress on which it is placed . AIMS The purpose of this study was to investigate short-term effects of varied post-natal lying positions in order to prevent neuromuscular and postural abnormalities . METHODS 60 low risk preterm infants of 31 - 36 weeks gestational age were enrolled for this r and omised clinical trial . Initially each child underwent neurological and psychomotor assessment s which included tonus and reflex protocol s as well as behavioral , sensory motor and postural examinations . The lying positions of the treated group were varied ( back , prone , and side ) using a specially design ed moldable mattress that maintained the functional position of the infant 's body . The control group was placed on their stomachs , ( the st and ard lying position used in 1994 ) with a st and ard orthopaedic bolster support under their hips . All infants underwent a second round of examinations upon discharge to assess any changes in neurological and psychomotor outcomes . RESULTS The sensory-motor skills examinations showed significant abnormalities in the control group : ( 1 ) dominance of the extensor muscles due to muscle shortening , ( 2 ) hyper abduction and flexion of the arms , and ( 3 ) global neuromuscular rigidity . Psychomotor and neurological exams of the control and treatment groups showed delayed developmental muscular acquisitions for infants in the control group . CONCLUSION Regular changes in posture , while retaining correct functional positions , allowed maintenance of normal neuromuscular and osteo-articular function and permitted the development of spontaneous and functional motor activity in low-risk perterm infants OBJECTIVE : The purpose of this study was to determine the effects of prone and supine positioning on the cardiorespiratory stability of preterm infants with apnea and bradycardia . METHODS : A total of 22 preterm infants with symptomatic apnea and bradycardia ( gestational age of 26.9 ± 1.8 weeks and birth weight of 865 ± 235 gm ) were monitored for 24 hours ( in four sequential 6-hour blocks ) for apnea , bradycardia , and oxygen desaturation in alternating positions ( prone or supine ) following r and omization . Postconceptional age at the time of study was 31.9 ± 3.0 weeks . Respiratory rate , heart rate , and transcutaneous oxygen saturation were continuously monitored . All episodes of apnea ( ≥10 seconds ) , bradycardia ( < 100 beats per minute ) , and oxygen desaturation ( < 90 % ) were recorded on an event monitor . Episodes of apnea , bradycardia , and oxygen desaturation were defined as clinical ly significant if the following criteria were met : apnea , ≥15 seconds ; bradycardia , < 90 beats per minute ; and oxygen desaturation , < 80 % . All other recorded episodes were considered mild . The episodes were analyzed for statistical significance using the paired t-test . RESULTS : No significant differences ( p > 0.05 ) in the incidence of clinical ly significant apnea , bradycardia , or desaturation between supine and prone positions were seen in these preterm infants . CONCLUSION : Our results suggest that the cardiorespiratory stability of preterm infants is not significantly compromised by supine positioning Objective The purpose of this study was to examine the influence of prone and supine position in preterm infants during acute pain of blood collection . Setting Level III Neonatal Intensive Care Unit ( NICU ) . Study Design Thirty-eight preterm infants ( birthweight 1339 [ 590–2525 ] g , GA 29 [ 25– 32 ] wks ) were in 2 groups depending on their position in the isolette prior to and during heel lance at 32 weeks post-conceptional age . The study design was a comparison between groups ( Prone , Supine ) during 2 events ( Baseline , Heel lance ) . Outcome MeasurePain measures were multidimensional , including behavioral ( sleep – wake state and facial activity ) and physiological ( heart rate ) responses measured continuously prior to ( Baseline ) and during blood collection ( Lance ) . Results Both groups of infants displayed statistically significant shifts in sleep – wake state to greater arousal , and increased facial activity and heart rate , from Baseline to Lance . Prone position was associated with significantly more deep sleep during Baseline , compared with Supine position , but there were no differences in sleep-wake state during Lance . Minor increased facial activity was shown in some time segments of Baseline for infants in Supine compared with Prone , but did not differ overall between positions . Prone and Supine position did not affect heart rate significantly during Baseline or Lance events . Conclusions Prone position promotes deep sleep in preterm neonates at 32 weeks post-conceptional age when they are undisturbed . However , placement in prone position is not a sufficient environmental comfort intervention for painful invasive procedures such as heel lance for blood sampling in the NICU . Neonates require other environmental supports to promote coping with this stressful event Background . As a result of the American Academy of Pediatrics ' recommendation that healthy infants be placed on their side or back for sleep , the percentage of infants sleeping prone has decreased dramatically . With the increase in supine sleeping , pediatricians have question ed if there are differences in the rate of acquisition of early motor milestones between prone and supine sleeping infants . Methods . To examine this question , we performed a prospect i ve , practice -based study of healthy term infants . Infants were recruited before the age of 2 months . Parents were asked to record infant sleep position and awake time spent prone until 6 months of age . A developmental log was used to track milestones from birth until the infant was walking . Age of acquisition of eight motor milestones was determined , and the mean ages of milestone attainment of prone and supine sleepers were compared . Results . Three hundred fifty-one infants completed the study . Prone sleepers acquired motor milestones at an earlier age than supine sleepers . There was a significant difference in the age of attainment of rolling prone to supine , tripod sitting , creeping , crawling , and pulling to st and . There was no significant difference in age when infants walked . Conclusions . The pattern of early motor development is affected by sleep position . Prone sleepers attain several motor milestones earlier than supine sleepers . However , all infants achieved all milestones within the accepted normal age range . Pediatricians can use this information to reassure parents . This difference in milestone attainment is not a reason to ab and on the American Academy of Pediatrics ' sleep position recommendations OBJECTIVE We investigated whether nursing in the head elevated tilt position ( HETP ) , compared with the horizontal position , has any effect on the incidence of bradycardic and hypoxemic episodes in preterm infants . METHODS Twelve spontaneously breathing preterm infants with idiopathic recurrent apnea were studied in a r and omized controlled crossover trial . Nine infants were treated with aminophylline . Each spent a total of 24 hours in the horizontal prone position and a total of 24 hours in HETP ( prone , 15 degrees ) . The position was changed in r and om order every 6 hours . Thoracic impedance , heart rate , and arterial oxygen saturation were recorded continuously . The frequency of isolated hypoxemia ( arterial saturation < 80 % ) , of isolated bradycardia ( heart rate < 90 beats per minute ) , and of mixed events was analyzed and compared without knowledge of the allocated position . RESULTS In total , there were significantly fewer bradycardic and /or hypoxemic episodes ( 28.2 % ) in HETP compared with the horizontal position ( mean difference , 13.35 episodes/24 hours ; 95 % confidence interval [ CI ] : 5.9- 20.8 ) . The decrease was largest for isolated hypoxemic episodes ( 48.5 % ; mean difference , 11.74 episodes/24 hours ; 95 % CI : 6.1 - 17.4 ) . Isolated bradycardic episodes ( mean difference , 2.27 episodes/24 hours ; 95 % CI : -0.78 - 5.31 ) and mixed events were not decreased significantly in HETP . CONCLUSIONS Nursing in a moderately tilted position ( 15 degrees ) reduces hypoxemic events in preterm infants . This intervention is easy to apply , quickly reversible , and can be combined with drugs such as aminophylline OBJECTIVE . Prematurely born compared with term born infants are at increased risk of sudden infant death syndrome , particularly if slept prone . The purpose of this work was to test the hypothesis that preterm infants with or without bronchopulmonary dysplasia being prepared for neonatal unit discharge would sleep longer and have less arousals and more central apneas in the prone position . METHODS . This was a prospect i ve observational study in a tertiary NICU . Twenty-four infants ( 14 with bronchopulmonary dysplasia ) with a median gestational age of 27 weeks were studied at a median postconceptional age of 37 weeks . Video polysomnographic recordings of 2-channel electroencephalogram , 2-channel electro-oculogram , nasal airflow , chest and abdominal wall movements , limb movements , electrocardiogram , and oxygen saturation were made in the supine and prone positions , each position maintained for 3 hours . The duration of sleep , sleep efficiency ( total sleep time/total recording time ) , and number and type of apneas , arousals , and awakenings were recorded . RESULTS . Overall , in the prone position , infants slept longer , had greater sleep efficiency ( 89.5 % vs 72.5 % ) , and had more central apneas ( median : 5.6 vs 2.2 ) , but fewer obstructive apneas ( 0.5 vs 0.9 ) . The infants had more awakenings ( 9.7 vs 3.5 ) and arousals per hour ( 13.6 vs 9.0 ) when supine . There were similar findings in the Output:	The results of this review support the prone position in preterm infants for improvement of arterial oxygen saturation , improved lung and chest wall synchrony of respiratory improvements , decreased incidence of apnea in infants with a clinical history of apnea , promoted sleep , and decreased gastroesophageal reflux . However , the prone position increased postural abnormalities , orthopaedic abnormalities of the feet , and delayed developmental musculature . The combined use of a postural support roll and a postural nappy while very preterm infants are nursed , improved hip and shoulder posture up to term postmenstrual age . The change in body position from horizontal to head-up tilt in very immature and unstable infants may affect the cerebral homodynamic . The management of position per se may not be sufficient for assisting preterm neonates to cope with the painful procedure . Furthermore , preterm infants are susceptible to oxygen desaturation in car seats and carrying slings . Prone positioning was shown to have many advantages for prematurely born infants . But the longer , deep sleep period and fewer awakenings associated with a prone position would support higher vulnerability for preterm infants to sudden infant death syndrome ( SIDS ) .
MS2691	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE To evaluate the efficacy and safety of ixabepilone in patients with metastatic breast cancer ( MBC ) resistant to anthracycline , taxane , and capecitabine , in this multicenter , phase II study . PATIENTS AND METHODS Patients with measurable disease who had tumor progression while receiving prior anthracycline , taxane , and capecitabine were enrolled . Ixabepilone 40 mg/m(2 ) monotherapy was administered as a 3-hour intravenous infusion on day 1 of a 21-day cycle . The primary end point was objective response rate ( ORR ) , assessed by an independent radiology facility ( IRF ) . RESULTS A total of 126 patients were treated and 113 were assessable for response . Patients were heavily pretreated : 88 % had received at least two lines of prior chemotherapy in the metastatic setting . IRF-assessed ORR was 11.5 % ( 95 % CI , 6.3 % to 18.9 % ) for response-assessable patients . Investigator-assessed ORR for all treated patients was 18.3 % ( 95 % CI , 11.9 % to 26.1 % ) . Fifty percent of patients achieved stable disease ( SD ) ; 14.3 % achieved SD > or= 6 months . Median duration of response and progression-free survival were 5.7 and 3.1 months , respectively . Median overall survival was 8.6 months . Patients received a median of 4.0 treatment cycles ( range , one to 16 cycles ) , and 25 % of patients received > or= eight cycles . Grade 3/4 treatment-related events included peripheral sensory neuropathy ( 14 % ) , fatigue/asthenia ( 13 % ) , myalgia ( 8 % ) , and stomatitis/mucositis ( 6 % ) . Resolution of grade 3/4 peripheral sensory neuropathy occurred after a median period of 5.4 weeks . CONCLUSION Ixabepilone demonstrated clear activity and a manageable safety profile in patients with MBC resistant to anthracycline , taxane , and capecitabine . Responses were durable and notable in patients who had not previously responded to multiple prior therapies Output:	Ixabepilone plus capecitabine has prolonged the median time to progression , increased overall survival and significantly increased response rates compared with capecitabine alone . Adverse events observed with the combination arm were generally manageable and well tolerated with neutropenia and febrile neutropenia , and peripheral neuropathy , myalgia , diarrhea , stomatitis and h and -foot syndrome were easily controlled . Ixabepilone plus capecitabine demonstrated clinical activity with an acceptable safety profile , which seems to be a valid option for patients with anthracycline-pretreated/resistant and taxane-resistant metastatic breast cancer
MS2692	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE We evaluated the impact of an intervention promoting sun protection behavior among children 2 to 11 years of age through schools and day care centers , primary care practice s , and recreation areas . METHODS Ten towns in New Hampshire were paired , then assigned r and omly to intervention or control status . The multicomponent SunSafe intervention was provided to children and caregivers through primary care practice s , day care centers , schools , and beach recreation areas . Training support and material s were provided by the SunSafe project , but project staff had no direct contact with children or parents in providing the intervention . All intervention components promoted the same message : avoid the sun between 11 AM and 3 PM , cover up using hats and protective clothing , use sun block with a sun protection factor > /=15 , and encourage sun protection among family and friends . The impact of the intervention was determined by observing children 's sun protection behavior at the beach during baseline compared with 1 year later . The primary outcomes of interest were changes in the proportion of children per town using at least some sun protection and changes in the proportion of children fully protected . Children were clustered by town , with the town thus being the unit of analysis . The primary care practice component included one practice meeting for clinicians and staff at which project staff presented background on skin cancer and how to promote its prevention ; a sun protection office system manual based on our previous work , which provided specific direction on how to share responsibility among office staff and clinicians in carrying out routines that promote sun protection ; and educational posters , pamphlets , and self-adhesive reminder notes design ed to enhance sun protection counseling . SunSafe removable tattoos and stickers were offered to children at well-child and illness visits during the summer months . Schools each received three project staff visits : a brief visit with the principal to describe the intervention and to answer questions ; an in-service program to educate teachers about skin cancer and to introduce curricular material s ; and help with one parent outreach program . Larger day care centers each received one project staff visit . An additional six smaller day care centers received curricular material s through the mail but no visits . Two similar sets of curricular material s were used , one for grade schools and the other for preschools and day care centers . Both emphasized the importance of sun protection rather than the danger of skin cancer . Material s emphasized dynamic activities modeled after the " Slip , Slop , Slap " and " SunSmart " programs and included new material developed to suit regional needs . Both manuals offered structured plans but also provided a variety of activities from which teachers could choose . Teachers agreed to devote a minimum of two class periods to these material s. For recreation areas , lifeguards in each of the intervention communities attended an in-service meeting , during which background about skin cancer prevention was presented by project staff . The project also provided displays about the ultraviolet ( UV ) light index and about sun protection to be posted at each beach . Subsequently , project staff called beach staff in each community each morning with the predicted UV index for the day to post on the display . Educational pamphlets about the UV index and free sun-block sample s were available to beachgoers through the lifeguards . One brief follow-up visit by project staff was made to each beach area to provide reinforcement . RESULTS We observed 1930 children . Use of some sunscreen on at least one body area increased in all 5 intervention towns compared with paired control towns . In intervention towns , this mean proportion increased from 0.56 of those observed at baseline to 0.76 of those observed postintervention , with a minimal increase among control town children . ( ABSTRACT Childhood and adolescence are critical periods in the etiology of subsequent melanoma and nonmelanocytic skin cancers . The aims of the study were ( a ) to develop a valid measure of solar protection in 9 to 11-year-old school students , ( b ) to evaluate the differential effectiveness of two interventions aim ed at changing solar protection in this age group , and ( c ) to identify the predictors of use of a high level of solar protection . A Solar Protection Behavior Diary was developed and vali date d during a pilot , after which 11 schools were r and omly allocated to one of three groups : intensive intervention ( 247 students ) , st and ard intervention ( 180 students ) , or control ( 185 students ) , with students in years 5 and 6 participating in the study . Students completed the vali date d diary ( for 5 days ) and a knowledge and attitudes question naire at pretest and at two posttest periods ( 4 weeks and 8 months after pretest ) . Results indicated that students in the intensive intervention group were significantly more likely to have used a high level of protection at both posttest periods compared to the control and st and ard intervention groups . There was no difference in the protection level of the control and st and ard intervention groups at either posttest , indicating that this minimal intervention was not effective in changing the solar protection behavior of the students . Students with a high level of solar protection at pretest were also significantly more likely to have a high level of protection at both posttest periods , and those with a greater number of opportunities to protect were less likely to protect at the second posttest The effects of supplementary computer instruction in house dust mite-avoidance measures on adherence to implementing measures , on home dust mite-allergen levels , and on symptomatology were investigated in 52 adult patients with mite-associated asthma . Twenty-six patients received conventional instruction ( counseling and written instruction ) and the other 26 patients received conventional plus 22 minutes of interactive computer-assisted instruction . Instructions were aim ed at mite-avoidance measures . Pre- and postinstruction dust sample s were collected , and adherence was monitored . All patients kept symptom diaries twice a day . Patients ' progress was followed for 12 weeks , and all patients completed the study . Adherence , number of observed and self-reported mite-avoidance measures implemented after visit , was higher for the computer group ( p = 0.023 ) . The computer-instructed group achieved significantly lower levels of mite allergen in bedroom carpets ( p = 0.004 ) with mean levels of mite allergen declining from 6.5 + /- 7.6 to 2.2 + /- 4.3 micrograms/gm of dust ( two-site monoclonal antibody assays ) , whereas levels for the conventional-instructed group did not change . Moreover , by study weeks 9 and 10 , the computer-instructed group was significantly less symptomatic ( p = 0.033 ) . Mean symptom scores for this group decreased from 12.4 to 7.7 , compared with 16.4 to 14.3 . Conventional instruction supplemented with computer instruction is suggested in mite education College and high-school students were administered a question naire to assess their knowledge about skin cancer , and afterward an educational program was design ed to correct the identified deficiencies . Results showed that the students were relatively uninformed about how to recognize and prevent skin cancer — high-school students more so than college students — but that their knowledge of the disease ( e.g. , risk factors , preventive measures , and identification of “ warning signs ” for early detection ) increased significantly after training . Some forgetting was noted at a 2-week follow-up but knowledge levels were still significantly higher than baseline . If these findings are representative of the general population , more preventive education will be needed in this area . This is especially true because the potentially deadly melanoma appears to be increasing at an alarming rate Excessive exposure to the sun 's ultraviolet radiation ( UVR ) contributes to the etiology of melanoma and nonmelanoma skin cancers . Many behaviors that increase lifetime risk of skin cancer -- sun exposure , sunburn , and lack of sun protection -- occur early in childhood . A 1-day school-based skin cancer prevention effort -- Sun Smart Day -- was implemented and evaluated in three elementary schools to improve fourth- grade rs ' knowledge , attitudes , and behaviors related to skin cancer prevention . A classroom-based skin cancer prevention lesson was compared to an interactive sun safety fair was vehicles for promoting comprehensive photoprotection . Sun Smart Day interventions had their greatest impact on fourth- grade rs ' awareness and knowledge of skin cancer and children 's increased knowledge persisted through the summer break . While both the classroom curriculum and the health fair boosted awareness and knowledge of sun safety among fourth grade rs , the classroom curriculum demonstrated a slight immediate advantage over the health fair on these outcomes . Also the curriculum was less difficult to implement , but the health fair was more engaging . A Sun Smart Day program may be an important first step in increasing public awareness and underst and ing of skin cancer and its prevention Children with asthma who are exposed to environmental tobacco smoke are at increased risk for adverse health consequences . An experimental design was used to evaluate a minimal-contact intervention aim ed at modifying parents ' smoking behavior in their homes . All subjects received counseling on the health effects of passive smoking and advice to quit smoking inside the home . Treatment subjects were also mailed the results of a urine cotinine test on their child and a self-help manual . More treatment ( 35 % ) than control ( 17 % ) subjects reported smoking outside their homes at posttest ( and their children 's cotinine levels were lower ) , but this difference was not statistically significant STUDY OBJECTIVE To examine the long-term maintenance of a previously reported behavioral counseling intervention to reduce asthmatic children 's exposure to environmental tobacco smoke ( ETS ) . PARTICIPANTS Families of asthmatic children ( 6 to 17 years ) , including at least one parent who smoked in the home , recruited from four pediatric allergy clinics . DESIGN Participants were r and omized to one of three groups : behavioral counseling to reduce ETS exposure , self-monitoring control , and usual medical care control . Counseling concluded at month 6 , and the original trial ended at month 12 . Two follow-up interviews occurred at months 20 and 30 . MEASUREMENTS AND RESULTS The originally reported analysis of baseline to 12 months was reanalyzed with a more robust restricted maximum likelihood procedure . The 2-year follow-up period was analyzed similarly . Significantly greater change occurred in the counseling group than the control groups and was sustained throughout the 2 years of follow-up . Further exploratory analyses suggested that printed counseling material s given to all participants at month 12 ( conclusion of the original study ) were associated with decreased exposure in the control groups . CONCLUSION Such long-term maintenance of behavior change is highly unusual in the general behavioral science literature , let alone for addictive behaviors . We conclude that ETS exposure can be reduced and that a clinician-delivered treatment may provide substantial benefit BACKGROUND Project SUNWISE evaluated the effectiveness of a multicomponent intervention in reducing children 's ultraviolet radiation ( UVR ) exposure . METHODS Across four YMCAs , 48 aquatics classes ( N = 169 children , mean age = 7 ) were r and omly assigned to either the intervention or the control condition . The 6-week intervention included a UVR reduction curriculum presented at poolside by aquatics instructors and home-based activities for children and their parents . Outcome measures were ( a ) tanness-associated skin color dimensions assessed with a colorimeter , ( b ) specific daily solar protection behaviors of children as reported by parents , and ( c ) general solar protection behaviors . RESULTS Controlling for intraclass clustering in all analyses , at posttest , no statistically significant between-group differences were found in tanness , daily solar protection scores , or general sunscreen use . The intervention group showed significantly greater general hat use relative to controls . CONCLUSIONS The intervention failed to impact most of the outcome measures . Supplementing the behavior-focused intervention package with environmental supports may be warranted OBJECTIVES This feasibility study examined whether a sun safety curriculum design ed for and administered to preschoolers affects their cognition ( knowledge , comprehension , application ) regarding sun safety . METHODS Twelve classes of 4- to 5-year-olds were recruited from local preschools and r and omly assigned to an intervention group or a control group . The intervention group received an investigator-developed sun safety curriculum ; the control group did not . Children in both groups were tested at the beginning of the study about their cognition related to sun safety . They then received posttests 2 and 7 weeks following the pretest . RESULTS The curriculum had a significant effect on the knowledge ( P = .01 ) and comprehension ( P = .006 ) components of cognition . The application component of cognition was not significantly changed by the curriculum . CONCLUSIONS A structured curriculum was found to be an efficacious means of enhancing knowledge and comprehension of sun safety in preschool children . At the preoperational developmental stage , however , children may not be able to apply such knowledge and comprehension Output:	CONCLUSIONS Positive short-term changes in health-protective awareness , knowledge and self-reported behaviour appear to be associated with relatively intensive interventions that use multiple methods and setting s , and /or are delivered over multiple sessions
MS2693	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items Background : Sex-related differences in the perception of pain and susceptibility to opioids remain a matter of debate . Intravenous morphine titration used to obtain pain relief in the immediate postoperative period is a unique clinical model for assessing the effect of sex on reported pain . Because of the wide variation in dose requirements for pain management , the authors conducted a prospect i ve study in a large population and also assessed the effect of aging . Methods : Intravenous morphine titration was administered as a bolus of 2 ( body weight ≪ 60 kg ) or 3 mg ( body weight > 60 kg ) during the immediate postoperative period . The interval between each bolus was 5 min . The visual analog pain scale ( VAS ) threshold required to administer morphine was 30 , and pain relief was defined as a VAS score of 30 or less . Data are expressed as mean ± SD . Results : Data from 4,317 patients were analyzed ; 54 % of the patients were male , and 46 % were female . The mean morphine dose required to obtain pain relief was 11.9 ± 6.8 mg or 0.173 ± 0.103 mg/kg . Women had a higher initial VAS score ( 74 ± 19 vs. 71 ± 19 ; P < 0.001 ) and required a greater dose of morphine ( 0.183 ± 0.111 vs. 0.165 ± 0.095 mg/kg ; P < 0.001 ) . In contrast , no significant difference was noted in elderly ( aged > 75 yr ) patients ( 0.163 ± 0.083 vs. 0.157 ± 0.085 mg/kg ) . Conclusion : Women experienced more severe postoperative pain and required a greater dose ( + 11 % ) of morphine than men in the immediate postoperative period . This sex-related difference disappeared in elderly patients BACKGROUND : IV morphine titration ( IMT ) is widely used in the postanesthesia care unit to achieve pain relief . Numerous factors contribute to variability in postoperative pain or morphine consumption . We analyzed prospect ively the pre- and intraoperative predictive factors of severe postoperative pain defined as a dose of IMT > 0.15 mg/kg or a failure of IMT . METHODS : We assessed the role of preoperative information about pain , medical treatments , and intraoperative events and their role on postoperative pain . After IMT , patients were divided into two groups : severe pain ( SP ) and nonsevere pain . Data are expressed as mean ± sd . RESULTS : Three hundred forty-two patients were included in the study : 200 ( 58 % ) in the nonsevere pain group and 142 ( 42 % ) in the SP group . Using a univariate analysis , there was no significant difference between groups related to medical or surgical history except for more frequent preoperative treatments in the SP group ( P < 0.05 ) . Duration of the surgical procedure and anesthesia were longer in the SP group ( P < 0.001 ) . The dose of sufentanil and visual analog scale scores before and at the end of IMT were higher in the SP group ( P < 0.001 ) . Using a multivariate analysis , a high dose of intraoperative opioid ( sufentanil dose > 0.6 μg/kg ) ( Odds ratio = 2.68 , P < 0.001 ) , a general anesthetic procedure ( Odd ratio = 3.96 , P = 0.03 ) , and the use of preoperative analgesic drugs ( Odds ratio = 1.91 , P < 0.01 ) were independent factors associated with severe postoperative pain . CONCLUSION : A higher intraoperative dose of sufentanil , general anesthesia , and preoperative treatment with analgesics were significantly associated with severe postoperative pain We have evaluated the level of state and trait anxiety , neuroticism , extroversion and coping style as predictors of the effectiveness of patient-controlled analgesia ( PCA ) in 110 patients undergoing total abdominal hysterectomy . After operation patients were allocated to receive pain control with either PCA or i.m . injections ( IMI ) . Pain was assessed using the short form McGill pain question naire at 6 , 18 and 24 h after operation , and by recording the amount of analgesic consumed in the first 24 h after surgery . Both state anxiety and coping style were significant predictors of postoperative pain , irrespective of the method of analgesia used . Patients using PCA experienced significantly better pain control than those receiving IMI . However , it was those with high levels of state anxiety who experienced the greatest reduction in pain with PCA . In addition to achieving better pain control , patients who received PCA used significantly less analgesia and were discharged earlier than patients who received IMI Postoperative pain is a common reason for the delayed discharge and unanticipated hospital admission of out patients .In this study , we examined the pattern of pain in ambulatory surgical patients and determined those factors that predict postoperative pain . Ten thous and eight consecutive ambulatory surgical patients were prospect ively studied . Preoperative patient characteristics , intraoperative variables , and pain in the postanesthesia care unit ( PACU ) and the ambulatory surgical unit ( ASU ) and 24 Output:	Gender was not found to be a consistent predictor as traditionally believed . Early identification of the predictors in patients at risk of postoperative pain will allow more effective intervention and better management .
MS2694	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The Fast Track prevention trial was used to test hypotheses from the Early-Starter Model of the development of chronic conduct problems . We r and omly assigned 891 high-risk first- grade boys and girls ( 51 % African American ) to receive the long-term Fast Track prevention or not . After 4 years , outcomes were assessed through teacher ratings , parent ratings , peer nominations , and child self-report . Positive effects of assignment to intervention were evident in teacher and parent ratings of conduct problems , peer social preference scores , and association with deviant peers . Assessment s of proximal goals of intervention ( e.g. , hostile attributional bias , problem-solving skill , harsh parental discipline , aggressive and prosocial behavior at home and school ) collected after grade 3 were found to partially mediate these effects . The findings are interpreted as consistent with developmental theory OBJECTIVE To evaluate the effect of the middle and junior high school Drug Abuse Resistance Education ( D.A.R.E. ) and D.A.R.E. Plus programs on drug use and violence . DESIGN R and omized controlled trial of 24 schools , with 3 conditions : D.A.R.E. only , D.A.R.E. Plus , and delayed program control . SETTING Schools and neighborhoods , primarily in Minneapolis-St Paul . PARTICIPANTS All seventh- grade students in 24 schools in the academic year 1999 - 2000 ( N = 6237 at baseline , 67.3 % were white , and there was 84.0 % retention at final follow-up ) . INTERVENTIONS The middle and junior high school D.A.R.E. curriculum in the 16 schools that received D.A.R.E. only and D.A.R.E. Plus . In the 8 schoolts that received D.A.R.E. Plus , additional components included a peer-led parental involvement classroom program called " On the VERGE , " youth-led extracurricular activities , community adult action teams , and postcard mailings to parents . The interventions were implemented during 2 school years , when the cohort was in the seventh and eighth grade s. MAIN OUTCOME MEASURES Self-reported tobacco , alcohol , and marijuana use ; multidrug use ; violence ; and victimization , assessed at the beginning and end of seventh grade and at the end of eighth grade . Growth curve analytic methods were used to assess changes over time by condition . RESULTS There were no significant differences between D.A.R.E. only and the controls ; significant differences among boys between D.A.R.E. Plus and controls for tobacco , alcohol , and multidrug use and victimization ; significant differences among boys between D.A.R.E. Plus and D.A.R.E. only in tobacco use and violence ; and no significant behavioral differences among girls . CONCLUSION D.A.R.E. Plus significantly enhanced the effectiveness of the D.A.R.E. curriculum among boys and was more effective than the delayed program controls , underscoring the potential for multiyear , multicomponent prevention programs and demonstrating sex differences in response to intervention programs CONTEXT Most studies of the long-term effects of early childhood educational interventions are of demonstration programs rather than large-scale public programs . Previous studies of one of the oldest federally funded preschool programs have reported positive effects on school performance , but effects on educational attainment and crime are unknown . OBJECTIVE To determine the long-term effectiveness of a federal center-based preschool and school-based intervention program for urban low-income children . DESIGN , SETTING , AND PARTICIPANTS Fifteen-year follow-up of a nonr and omized , matched-group cohort of 1539 low-income , mostly black children born in 1980 and enrolled in alternative early childhood programs in 25 sites in Chicago , Ill. INTERVENTIONS The Chicago Child-Parent Center ( CPC ) Program ( n = 989 children ) provides comprehensive education , family , and health services and includes half-day preschool at ages 3 to 4 years , half- or full-day kindergarten , and school-age services in linked elementary schools at ages 6 to 9 years . The comparison group ( n = 550 ) consisted of children who participated in alternative early childhood programs ( full-day kindergarten ) : 374 in the preschool comparison group from 5 r and omly selected schools plus 2 others that provided full-day kindergarten and additional instructional re sources and 176 who attended full-day kindergartens in 6 CPCs without preschool participation . MAIN OUTCOME MEASURES Rates of high school completion and school dropout by age 20 years , juvenile arrests for violent and nonviolent offenses , and grade retention and special education placement by age 18 years . RESULTS Relative to the preschool comparison group and adjusted for several covariates , children who participated in the preschool intervention for 1 or 2 years had a higher rate of high school completion ( 49.7 % vs 38.5 % ; P = .01 ) ; more years of completed education ( 10.6 vs 10.2 ; P = .03 ) ; and lower rates of juvenile arrest ( 16.9 % vs 25.1 % ; P = .003 ) , violent arrests ( 9.0 % vs 15.3 % ; P = .002 ) , and school dropout ( 46.7 % vs 55.0 % ; P = .047 ) . Both preschool and school-age participation were significantly associated with lower rates of grade retention and special education services . The effects of preschool participation on educational attainment were greater for boys than girls , especially in reducing school dropout rates ( P = .03 ) . Relative to less extensive participation , children with extended program participation from preschool through second or third grade also experienced lower rates of grade retention ( 21.9 % vs 32.3 % ; P = .001 ) and special education ( 13.5 % vs 20.7 % ; P = .004 ) . CONCLUSIONS Participation in an established early childhood intervention for low-income children was associated with better educational and social outcomes up to age 20 years . These findings are among the strongest evidence that established programs administered through public schools can promote children 's long-term success Annual screenings of preschool children at kindergarten registration identified 158 children having high levels of aggressive , hyperactive , impulsive , and inattentive behavior . These " disruptive " children were r and omly assigned to four treatment conditions lasting the kindergarten school year : no treatment , parent training only , full-day treatment classroom only , and the combination of parent training with the classroom treatment . Results showed that parent training produced no significant treatment effects , probably owing largely to poor attendance . The classroom treatment produced improvement in multiple domains : parent ratings of adaptive behavior , teacher ratings of attention , aggression , self-control , and social skills , as well as direct observations of externalizing behavior in the classroom . Neither treatment improved academic achievement skills or parent ratings of home behavior problems , nor were effects evident on any lab measures of attention , impulse control , or mother-child interactions . It is concluded that when parent training is offered at school registration to parents of disruptive children identified through a brief school registration screening , it may not be a useful approach to treating the home and community behavioral problems of such children . The kindergarten classroom intervention was far more effective in reducing the perceived behavioral problems and impaired social skills of these children . Even so , most treatment effects were specific to the school environment and did not affect achievement skills . These findings must be viewed as tentative until follow-up evaluations can be done to determine the long-term outcomes of these interventions BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes OBJECTIVE This study compared the efficacy of a media literacy program and a self-esteem program design ed to reduce general and specific risk factors for eating disorders . METHOD Four classes of 86 grade 8 students ( 53 boys and 33 girls ) , mean age of 13 years , were r and omly assigned to either a control condition or one of the two intervention conditions . Assessment of general and specific risk factors was carried out at baseline , postintervention and 3-month follow-up . RESULTS At postintervention the media literacy group had lower mean scores on weight concern than the control group ( p = 0.007 ) but the self-esteem group did not . There were some differences on self-esteem measures at the 3-month follow-up . DISCUSSION Media literacy programs combined with an interactive , student-centered framework may potentially be a safe and effective way of reducing risk factors for eating disorders . The impact of teaching style needs to be further evaluated in prevention research OBJECTIVE As psychoeducational eating disorder prevention programs have not been shown to reduce bulimic pathology , we developed and evaluated a dissonance-based intervention for high-risk population s. METHOD Young women ( N = 87 ) with body image concerns were r and omized to this intervention , which involves verbal , written , and behavioral exercises requiring them to critique the thin-ideal , or to a healthy weight management control group . Participants completed a baseline , termination , and 4-week follow-up survey . RESULTS Participants in the dissonance intervention reported decreased thin-ideal internalization , body dissatisfaction , dieting , negative affect , and bulimic symptoms at termination and at 4-week follow-up . Unexpectedly , participants in the healthy weight management control group also reported some benefits . DISCUSSION Taken in conjunction with past findings , these preliminary results suggest that the dissonance intervention , and to a lesser extent the healthy weight management intervention , may reduce bulimic pathology and risk factors for eating disturbances OBJECTIVES We examined the effectiveness of the Signs of Suicide ( SOS ) prevention program in reducing suicidal behavior . METHODS Twenty-one hundred students in 5 high schools in Columbus , Ga , and Hartford , Conn , were r and omly assigned to intervention and control groups . Self-administered question naires were completed by students in both groups approximately 3 months after program implementation . RESULTS Significantly lower rates of suicide attempts and greater knowledge and more adaptive attitudes about depression and suicide were observed among students in the intervention group . The modest changes in knowledge and attitudes partially explained the beneficial effects of the program . CONCLUSIONS SOS is the first school-based suicide prevention program to demonstrate significant reductions in self-reported suicide attempts Project Northl and was a r and omized trial to reduce alcohol use among adolescents in 24 school districts in northeastern Minnesota . Phase 1 ( 1991 - 1994 ) , when the targeted cohort was in grade s 6 - 8 , included school curricula , parent involvement , peer leadership and community task forces . The Interim Phase ( 1994 - 1996 ) involved minimal intervention . Phase 2 ( 1996 - 1998 ) , when the cohort was in grade s 11 and 12 , included a classroom curriculum , parent education , print media , youth development and community organizing . Outcomes of these interventions were assessed by annual student surveys from 1991 to 1998 , alcohol purchase attempts by young-looking buyers in 1991 , 1994 and 1998 , and parent telephone surveys in 1996 and 1998 . Growth curve analysis was used to examine the student survey data over time . Project Northl and was most successful when the students were young adolescents . The lack of intervention in the Interim Phase when the students were in grade s 9 and 10 had a significant and negative impact on alcohol use . The intervention used with the high school students as those in grade s 11 and 12 made a positive impact on their tendency to use alcohol use , binge drinking and ability to obtain alcohol . There was no impact in Phase 2 on other student-level behavioral and psychosocial factors . Developmentally appropriate , multi-component , community-wide programs throughout adolescence appear to be needed to reduce alcohol use Thirty-seven families who had a child between the ages of 8 and 15 ( mean age = 12.0 years ) and had at least one parent , who had experienced a recent episode of affective disorder were assigned r and omly to one of two psy Output:	Telepsychiatry and the internet seem to be the most promising strategies to diffuse knowledge with lower costs .
MS2695	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This r and omized controlled trial investigated the effect of live music on quality of life and depression in 47 older people with dementia using the Dementia Quality of Life and Geriatric Depression Scale . The control/reading group reported higher mid-point feelings of belonging than the music group ( F(1 , 45 ) = 6.672 , p < .05 ) . Sub-analyses of ≥ 50 per cent music session attendance found improvements in self-esteem over time ( F(2 , 46 ) = 4.471 , p < .05 ) . Participants with scores that were suggestive of increased depressive symptoms had fewer depressive symptoms over time ( F(2 , 22 ) = 8.129 , p < .01 ) . Findings suggest music and reading activities can improve self-esteem , belonging and depression in some older people with dementia This study aim ed to investigate the long-term effects of group music therapy on agitation manifested by nursing home residents with Alzheimer 's disease . A non-r and omised experimental design was employed with one group receiving weekly music therapy ( n = 26 ) and another group receiving st and ard nursing home care ( n = 19 ) . Agitation levels were measured five times over one year using the Cohen-Mansfield Agitation Inventory ( Cohen-Mansfield , J. ( 1989 ) . Agitation in the elderly . In N. Billig & P. V. Rabins ( Eds . ) , Issues in geriatric psychiatry ( pp . 101–113 ) . Basel , Switzerl and : Karger ) . Although music therapy participants showed short-term reductions in agitation , there were no significant differences between the groups in the range , frequency , and severity of agitated behaviours manifested over time . Multiple measures of treatment efficacy are necessary to better underst and the long-term effects music therapy programs have on this population Objective : Reminiscence therapy is a psychological intervention which is specifically design ed to address issues of particular relevance to older adults , such as depression . The latest approach to the research on therapeutic utility of reminiscence is gaining popularity among research ers and practitioners , and has yielded promising results . Specifying different types of reminiscence is a crucial component of the approach . The aim of this study was to examine the therapeutic effectiveness of integrative and instrumental types of reminiscence for the treatment of depression in institutionalized older adults dwelling in a nursing home . Method : The study employed a three-group pre – post-test design with r and om allocation to instrumental or integrative reminiscence or an active social discussion control condition . Twenty-nine institutionalized older adults ( 12 men and 17 women ) with depressive symptoms varying from mild to severe constituted the sample . The interventions were implemented in a short-form group format . Findings : Analysis of changes from pre-test to post-test revealed that integrative reminiscence therapy led to statistically significant reduction in symptoms of depression in contrast with the control group . Although instrumental reminiscence therapy also reduced depressive symptoms , this improvement was not statistically significant compared to the control group . Conclusion : This study provides additional support for the effectiveness of integrative reminiscence therapy as an intervention for depressed older adults living in residential care setting s. This study also provides support for the hypothesis that certain types of reminiscence produce their own specific effects Objectives : To evaluate the effect of different pathways for developing a life story book ( LSB ) for people with dementia . Method : Preliminary r and omised control trial ; 23 people with dementia in care homes ( mean age 86 ) r and omly assigned to receive either 12 individual life review sessions and co-creating a LSB or a personal LSB created by their relatives as a ‘ gift ’ Results : No difference in quality of life ( quality of life – Alzheimer 's disease ( QOL – AD ) ) was observed between the two groups , six weeks after having received the LSB ( F(1,20 ) = 0.08 , p = 0.77 ) . At this point , QOL – AD had improved for both groups , but there was a significant between-group difference at an intermediate assessment immediately after the life review sessions had been completed , before the LSBs were received ( F(1 , 20 ) = 5.11 , p = 0.035 ) , in favour of life review . A similar pattern was observed on autobiographical memory ( extended autobiographical memory interview ) , with the life review group improving significantly more than the gift group during the life review sessions , but no difference was observed once all participants had had their LSB for six weeks . After the LSBs were produced – by either pathway – quality of relationship as rated by relatives improved significantly ( F(2 , 39 ) = 19.37 , p < 0.001 ) and staff knowledge regarding the resident and attitudes to dementia improved . Conclusion : The creation of LSBs – either through a life review process or by relatives without involving the person with dementia – has benefits for people with dementia , relatives and staff in care homes . However , undertaking a life review requires training and supervision OBJECTIVE To examine effects of individual thematically-based reminiscence sessions based on the SolCos model for older adults with dementia because of Alzheimer disease ( AD ) as a pilot study . BACKGROUND Reminiscence activities are popular within nursing homes and generally considered to be enjoyable and helpful , however , there is a paucity of robust data demonstrating therapeutic impact . Criticisms of existing reminiscence studies include the failure to explicate the reminiscence protocol and to st and ardize delivery and choice of outcome measures . METHODS In this study , 82 older adults with probable AD were recruited from psychiatric day care , inpatient , and long term care facilities . Of the study group , 41 participants were r and omly selected for individual reminiscence sessions during 4 weeks performed by 1 facilitator . A control group of 41 older adults were r and omly involved and had no planned reminiscence treatment of any kind in the study period . All study participants were tested pre- and postintervention period with vali date d assessment scales to evaluate cognition and behavior . Analyses were based on delta scores , the differences between assessment scales pre- and postintervention scores , compared between the intervention and the control group . RESULTS A structured reminiscence protocol was developed with user involvement , and intervention group participants received 6 - 8 reminiscence sessions ( average 7.4 ) . The primary outcomes of Mini- Mental State Examination ( MMSE ) and Geriatric Depression Scale ( GDS-30 ) delta scores of the intervention group were significantly better than those of the control group . Participants of the intervention group with both mild and moderate AD had significantly better GDS-30 delta scores compared with the control group . Significantly better MMSE delta scores were found only in the intervention sub-group with moderate AD . Logistic regression analyses with all study participants showed an impact of reminiscence sessions on depressive symptoms measured with GDS-30 . CONCLUSIONS The pilot study results showed positive effects associated with individual thematically-based reminiscence on well-being such as depressive symptoms and cognition of participants . This is an encouraging finding after a relatively short period . Further study is necessary to confirm these results , determine sustainability and optimal delivery methods WHAT IS KNOWN ON THE SUBJECT ? : To stimulate reminiscence of older adults with dementia performed individually or through group sessions is a well-known practice in nursing homes result ing in effects on behaviour and well-being as an alternative for medication . Robust scientific proof of the effectiveness of individual reminiscence therapy performed in nursing homes is sparse . WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE ? : We have provided individual st and ardized reminiscence therapy to residents with dementia . The therapy was developed and tested in a previous study and performed in this study by trained nursing home volunteers . In comparison with a control group who received usual care , residents who received the reminiscence therapy showed significant less depressive symptoms . Moreover , residents were , in general , attentive , open and collaborative during the sessions and volunteers experienced the sessions as useful and pleasant . WHAT ARE THE IMPLICATION S FOR PRACTICE ? : Individual reminiscence therapy can be learned and used by nursing home volunteers to improve care in nursing homes . ABSTRACT Aim To investigate the effect of a st and ardized individualized intervention based on the SolCos transformational reminiscence model on depressive symptoms ( primary outcome ) , cognition and behaviour ( secondary outcomes ) for older people with mild to moderate dementia , performed by trained nursing home volunteers as facilitators . Background Because of limited pharmacological treatment options for older adults with dementia relevant physical , sensory , psychological or social interventions offer alternative opportunities . Method R and omized controlled trial ( IS RCT N74355073 ) was set up in two nursing homes with 29 and 31 residents in the intervention and the control groups respectively . Eighteen nursing home volunteers were trained to perform the reminiscence therapy . Various assessment scales were measured pre- and post-sessions . Results Linear regression analysis showed an impact on depressive symptoms . However , no impact was identified on cognition and behaviour . Facilitators experienced the sessions as useful and pleasant , and study participants were , in general , attentive , open and collaborative . Discussion Study results showed that organizing st and ardized individual reminiscence therapy with nursing home volunteers was feasible and study participants ' attention and participation were overall good . Further study initiatives to explore the potential of individual reminiscence therapy within a person-centred framework are recommended in order to improve care in nursing homes BACKGROUND Elderly people with cognitive impairments are often associated with depressed mood and are heavy consumers in both medical services and need in caregivers . Reminiscence is believed to be effective in improving the cognition and mood of demented people . OBJECTIVES This study tested the hypothesis that structured group reminiscence therapy can prevent the progression of cognitive impairment and enhance affective function in the cognitively impaired elderly . METHODS A r and omized controlled trial ( RCT ) based on a two group pre- and post-test design was used . The experimental subjects underwent eight group sessions , one session per week . The measurements were performed using Mini-Mental State Examination ( MMSE ) , Geriatric Depression Scale short form ( GDS-SF ) , and Cornell Scale for Depression in Dementia ( CSDD ) . RESULTS The sample consisted of 102 subjects , with 51 in the experimental group and 51 in the control group . Results demonstrated that the intervention significantly affected cognitive function and affective function as measured by MMSE and CSDD ( p = 0.015 and 0.026 ) , indicating that the cognitive function of the experimental subjects increased and their depressive symptoms diminished following intervention . CONCLUSION Participation in reminiscence activities can be a positive and valuable experience for demented older persons . Consequently , the development of a structured care program for elderly persons with cognitive impairment and the need for long-term care is essential . Thus , health providers in long-term care facilities should be trained in reminiscence group therapy , and to be able to deliver such a program to the targeted group BACKGROUND There is increasing recognition of the potential use of reminiscence in maintaining or improving the quality of life of people with dementia . Despite being used widely in dementia care , evidence on the effectiveness of reminiscence remains uncertain . AIMS This study aims to evaluate the effectiveness of a structured education-based reminiscence programme-the Dementia Education Programme Incorporating Reminiscence for Staff-for people with dementia residing in long-stay care setting s in Irel and . METHODS Dementia Education Programme Incorporating Reminiscence for Staff is a two-group , single-blind , cluster r and omised trial conducted in long-stay residential care setting s in Irel and . The primary outcome was the self-rated quality of life of residents as measured by the Quality of Life-Alzheimer 's Disease instrument . RESULTS Using an intention-to-treat analysis , we found that the estimated effect of the intervention on the quality of life of residents was a non-significant 3.54 ( p = 0.1 ; 95 % confidence interval -0.83 , 7.90 ) , expressed as the difference in mean improvement between the intervention and control groups . However , the per- protocol analysis yielded a significant effect for the intervention on the quality of life of residents of 5.22 ( p = 0.04 ; 95 % confidence interval 0.11 , 10.34 ) . CONCLUSIONS Reminiscence may , in certain circumstances , be an effective care option for people with dementia in long-stay setting s with potential to impact positively on the quality of life of residents The purpose of this study was , conducted with experimental design , to investigate the effect of reminiscence therapy on cognition , depression , activities of daily living of institutionalized mild and moderate Alzheimer patients . The study was conducted with a total of 62 patients ( 31 intervention group and 31 control group ) in four home care in Ankara , Turkey . Study was done between the July 1 , 2013 and December 20 , 2014 . Reminiscence therapy sessions were held with groups consists of 4 - 5 patients , once a week with 30 - 35 minute duration for 12 weeks . St and ardized Mini Mental Test was used in sample selection . Patients were listed through their mini mental test scores , and r and omized as odd numbers to control group and even numbers to intervention group . Data were collected with forms developed by research er ‘ Data Sheet ’ and ‘ Activities of Daily Living Follow-up Form ’ as well as scales ‘ St and ardized Mini Mental Test ’ and ‘ Geriatric Depression Scale ’ . Chi-square , Mann Whitney-U test , variance analyses in repeated measures and Bonferroni tests were used for analysis . The increase in mean St and ardized Mini Mental Test score and the decrease in mean Geriatric Depression Scale score of the individuals in the inter Output:	CONCLUSION Reminiscence therapy is an effective non-pharmacological therapy to improve depressive symptoms in older adults with dementia .
MS2696	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To evaluate prospect ively the efficacy and safety of 1 intravitreal injection of 4 mg of triamcinolone acetonide for refractory diffuse diabetic macular edema . DESIGN Interventional case series . PARTICIPANTS Fifteen patients with bilateral diabetic macular edema unresponsive to laser photocoagulation . In all patients , one eye received the injection , and the other served as a control . INTERVENTION Intravitreal injection of 4 mg of triamcinolone acetonide under subconjunctival anesthesia . MAIN OUTCOME MEASURES The main outcome measure was central macular thickness ( CMT ) at 1 , 3 , and 6 months , measured by optical coherence tomography . Secondary outcomes were Early Treatment Diabetic Retinopathy Study ( ETDRS ) scores , intraocular pressure , and cataract progression . RESULTS In this preliminary report , we give the results for 12 patients who had a follow-up of at least 3 months . Seven of them were followed up for 6 months . Before injection , CMT was 509.6+/-143.5 microm ( mean + /- st and ard deviation [ SD ] ) in injected eyes , versus 474.4+/-82.6 microm in control eyes . Four weeks after injection , it was 207.3+/-44.2 microm in injected eyes and 506.7+/-122.4 microm in control eyes ( P<0.001 , bilateral Wilcoxon test for paired sample s ) , and after 12 weeks , 207+/-96.7 microm and 469.3+/-117.6 microm , respectively ( P = 0.005 ) . The difference between the CMTs of injected and control eyes was no longer significant at 24 weeks because of the recurrence of macular edema in 5 of 12 injected eyes . Before triamcinolone injection , the ETDRS score was 47.8+/-13 ( mean + /- SD ; range , 28 - 66 ) in injected eyes , versus 51.9+/-14.6 ( range , 31 - 71 ) in control eyes . Twelve weeks thereafter , the corresponding values were 52.7+/-10.8 ( range , 34 - 70 ) and 50.8+/-14.3 ( range , 29 - 69 ) , respectively , and at 24 weeks , 54.7+/-7.6 ( range , 47 - 68 ) and 50.6+/-18.4 ( range , 28 - 71 ) . At no time was the difference between the ETDRS scores for injected and control eyes significant . In 6 of the 12 injected eyes , intraocular pressure exceeded 25 mmHg , and was controlled by topical medication . CONCLUSION Intravitreal injection of triamcinolone effectively reduces macular thickening due to diffuse diabetic macular edema , at least in the short term . Further studies are required to demonstrate that it provides visual benefit PURPOSE To compare the effectiveness of posterior sub-Tenon 's infusion ( STi ) and intravitreal injection ( IVI ) of triamcinolone acetonide ( TA ) for treatment of refractory diffuse diabetic macular edema . METHODS Thirty-six phakic diabetic patients with refractory diffuse diabetic macular edema were prospect ively enrolled . Patients r and omly received either 40 mg STi or 4 mg IVI of TA . Comprehensive ophthalmic evaluation was performed at baseline and 1 , 2 , 4 , 8 + /- 1 , 12 + /- 2 and 24 + /- 2 weeks after treatment . Macular morphologic changes detected by optical coherence tomography and visual acuity , intraocular pressure , and lens status were evaluated . RESULTS Twenty-eight patients ( 28 eyes ) completed the 24-week study . Central macular thickness was significantly reduced in the IVI group when compared with the STi group at 2 , 4 , 8 , 12 , and 24 weeks after treatment ( P < 0.01 ) . Mean visual acuities ( in logarithm of the minimum angle of resolution [ logMAR ] ) at week-4 , -8 , and -12 follow-up examinations were significantly higher in the IVI group ( 0.74 , 0.75 , and 0.82 , respectively ) when compared with the STi group ( 0.88 , 0.88 , and 0.90 , respectively ; P < 0.01 ) . A significant change from baseline in mean intraocular pressure ( mm Hg ) was seen at weeks 4 ( + /-3.21 ) and 8 ( + /-3.35 ) in STi the group ( P < 0.01 ) , and at week 8 ( + /-2.78 ) in the IVI group ( P < 0.05 ) . No patient had cataract progression during the study . CONCLUSIONS Although the number of patients and length of follow-up in this preliminary study were limited , the changes in central macular thickness and visual acuity observed after treatment suggest that IVI TA may be more effective than STi for the management of refractory diffuse diabetic macular edema . Further studies are needed to confirm these preliminary findings OBJECTIVE The epidemiological risk factors for the different forms of diabetic macular edema ( focal or diffuse ) are not differentiated in the literature . In the present study , the objective was to determine which risk factors influence the appearance of focal or diffuse macular edema . RESEARCH , DESIGN , AND METHODS : A 4-year prospect i ve study in a population of Type II diabetic patients ( NIDDM ) in three groups , the first with 29 patients with diffuse diabetic macular edema ( Group A ) , the second with 32 patients with focal macular edema ( Group B ) , and the third with 32 patients with diabetic retinopathy but without diabetic macular edema ( Group C ) ; the three groups were selected on the basis of sex , age , and duration of diabetes with similar patterns . We studied the following risk factors : treatment of diabetes mellitus by insulin , presence of diastolic blood hypertension , presence of microalbuminuria or diabetic nephropathy , levels of HbA1c , type of diabetic retinopathy , presence of previous panretinal photocoagulation , and levels of triglycerides and fractions of cholesterol . RESULTS In discriminant analysis and in order of importance , the epidemiological risk factors for Group A were the following : presence of panretinal laser , diastolic blood hypertension , diabetic nephropathy , and insulin treatment ; for group B , the risk factors were the following : insulin treatment , presence of diastolic blood hypertension , and high levels of glycated haemoglobin ( HbA1c ) ; and for group , C the risk factors were the following : diastolic blood hypertension , insulin treatment of diabetes , and high levels of HbA1c . CONCLUSIONS In the present study , the group of patients with focal macular edema were epidemiologically similar to the group of patients with diabetic retinopathy without macular edema , the group of patients with diffuse macular edema were epidemiologically different OBJECTIVE To evaluate the clinical outcome of an intravitreal injection of triamcinolone acetonide as treatment of diffuse diabetic macular edema . PARTICIPANTS This prospect i ve , interventional , clinical case series study included 20 patients ( 26 eyes ) who received an intravitreal injection of 25 mg of triamcinolone acetonide for treatment of diffuse diabetic macular edema . Mean + /- SD follow-up time was 6.64 + /- 6.10 months . The study group was compared with a control group of 16 patients who underwent macular grid laser coagulation . MAIN OUTCOME MEASURES Visual acuity and intraocular pressure . RESULTS In the study group , visual acuity improved significantly ( P<.001 ) , from 0.12 + /- 0.08 at baseline to a maximum of 0.19 + /- 0.14 during follow-up . Seventeen ( 81 % ) of 21 eyes with a follow-up period of more than 1 month had improved visual acuity . In the control group , visual acuity did not change significantly . In the study group , intraocular pressure increased significantly ( P<.001 ) , from 16.9 + /- 2.5 mm Hg to a mean maximal value of 21.3 + /- 4.7 mm Hg , and decreased significantly ( P = .03 ) to 17.7 + /- 4.7 mm Hg at the study 's end . CONCLUSION Intravitreal injection of 25 mg of triamcinolone acetonide may be beneficial for improving visual acuity in patients with clinical ly significant diffuse diabetic macular edema Aim : To evaluate the effect of different doses of intravitreal triamcinolone acetonide on diffuse diabetic macular oedema . Methods : The prospect i ve , r and omised , double masked , clinical interventional study included 27 eyes ( 27 patients ) with diffuse diabetic macular oedema . They were r and omly divided into three study groups receiving an intravitreal injection of filtered triamcinolone acetonide of about 2 mg ( n = 8 eyes ) , 5 mg ( n = 10 ) , or 13 mg ( n = 9 ) , respectively . Dosage measurement was performed before filtration . Mean follow up was 6.6 ( SD 2.4 ) months ( 3–12 months ) . Main outcome measures were visual acuity and intraocular pressure . Results : Maximal increase in visual acuity was significantly ( p = 0.046 ; 95 % CI : 0.032 to 2.99 ; r = 0.38 ) correlated with the dosage of intravitreal triamcinolone acetonide . Additionally , the duration of the effect of intravitreal triamcinolone acetonide increased significantly with the dosage of intravitreal triamcinolone acetonide ( r = 0.45 ; p = 0.014 ) . Increase in intraocular pressure during follow up was statistically not significantly associated with the dosage used ( p = 0.77 ) . Conclusions : In patients with diffuse diabetic macular oedema receiving intravitreal triamcinolone acetonide , treatment response may last longer and be more pronounced with a dosage of 13 mg than in lower doses of 5 mg or 2 mg . Triamcinolone acetonide induced increase in intraocular pressure may not be markedly associated with the dosage used PURPOSE To report on visual outcome of patients receiving intravitreal triamcinolone acetonide for treatment of diffuse diabetic macular edema . DESIGN Prospect i ve , comparative clinical interventional study . METHODS SETTING Institutional . patient population : The study included 25 consecutive patients ( 50 eyes ) with bilateral diabetic macular edema . Intervention procedure : Unilateral intravitreal injection of about 20 mg triamcinolone acetonide into the eye ( study group ) more severely affected by diabetic maculopathy . The contralateral eyes served as control group . Mean follow-up was 7.1 + /- 4.1 months . MAIN OUTCOME MEASURE Visual acuity , intraocular pressure . RESULTS In the study group , visual acuity increased significantly ( P < or = .001 ) by 3.0 + /- 2.6 Snellen lines to a peak at two to six months after the injection , and decreased significantly ( P = .001 ) towards the end of follow up . At the end of follow-up , visual acuity was higher , not significantly ( P = .18 ) higher , than at baseline . An increase in visual acuity was found in 23 eyes ( 92 % ) . In the control group , differences between visual acuity at baseline and at any of the re-examinations during follow-up were not significant ( P > .10 ) . In an intra-individual inter-eye comparison , gain in visual acuity was significantly ( P < .05 ) higher in the injected eyes , for the measurements obtained up to four months after injection . CONCLUSIONS Intravitreal triamcinolone acetonide may temporarily increase visual acuity in eyes with diabetic macular edema PURPOSE The aim of this study was to examine the visual outcome of patients receiving an intravitreal injection of triamcinolone acetonide ( TA ) as treatment of diffuse diabetic macular edema ( DDME ) . METHODS This prospect i ve , placebo-controlled , r and omized , clinical interventional study included 40 eyes ( 38 patients ) with DDME , with 28 ( 70 % ) eyes r and omized to treatment and 12 ( 30 % ) eyes r and omized to receive a placebo injection . Thirty-six ( 36 ) ( 90 % ) eyes completed the 3-month study visit , and 32 ( 80 % ) eyes completed the 6-month study visit . The treatment group received an intravitreal injection of approximately 20 mg of TA . RESULTS Visual acuity increased significantly ( P < 0.001 ) in the study group by 3.4 + /- 2.5 Snellen lines . In the control group , visual acuity did not change significantly ( P = 0.07 ) during follow-up . Difference in change of best visual acuity was significant ( P < 0.001 ) between both groups . At 3 months after baseline , 11 ( 1 Output:	Increased intraocular pressure and cataract formation were side effects requiring monitoring and management . RCTs included in this review suggest that steroids placed inside the eye by either intravitreal injection or surgical implantation may improve visual outcomes in eyes with persistent or refractory DME . Since the studies in our report focused on chronic or refractory DME , the question arises whether intravitreal steroids therapy could be of value in other stages of DME , especially the earlier stages either as st and alone therapy or in combination with other therapies , such as laser photocoagulation
MS2697	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The objective of our study was to compare prospect ively the QoL in long‐term ovarian cancer survivors with short‐term survivors and to explore discriminating variables between short‐term and long‐term survival . Thirty‐three patients were included , 22 died within 5 years post diagnosis and 11 survived beyond 10 years . QoL data were collected pre‐treatment ( baseline ) , 1‐year post diagnoses and for long‐term survivors 10 years post‐treatment using the EORTC QLQ‐C30 . At baseline , there was no difference in terms of FIGO stage , residual tumor and adjuvant chemotherapy . Significantly , more short‐term survivors ( 96 % ) had intra operative ascites as compared to long‐term survivors ( 55 % ) ( p=0.01 ) . Before treatment , short‐term survivors had clinical ly significantly lower QoL scores on the physical functioning ( mean 75.45 ) and role functioning scale ( mean 68.94 ) compared to long‐term survivors ( mean 68.94 and 84.85 , respectively ) . They also reported higher levels of symptoms . One year post‐diagnosis , QoL scores were comparable in most domains . Long‐term survivors had a significantly better global QoL but more insomnia . Emotional functioning and global QoL/health status improved significantly from baseline to 1‐year post‐diagnosis and remained relatively stable at the 10‐year follow‐up . The presence of intra operative ascites and a supporting social network were identified as significant variables that discriminated between short‐term and long‐term survival . Compared to a reference sample , long‐term survivors showed similar QoL scores but more dyspnoea . Although ovarian cancer patients do not belong to the most prevalent survivor population s , we found that long‐term survivors have QoL scores similar to females without a history of cancer Background Surgeons , along with the Centers for Disease Control and Prevention , emphasize the importance of managing symptoms and improving the quality of life of cancer survivors . A 2008 meta- analysis of mindfulness-based stress reduction ( MBSR ) concluded that this technique might improve patients ’ adjustment to their disease . However , r and omized controlled trials using st and ardized measures for evaluating MBSR are limited . The primary objective of this study was to evaluate , using valid and reliable measures , the effects of a unique , interactive , 8-week cancer recovery and wellness program on symptoms and quality of life of female cancer survivors . Methods Sixty-eight female cancer patients were r and omized into either an intervention or waitlisted control group . Patients were evaluated using the Symptoms Checklist ( SCL-90-R ) , the European Organization for Research and Treatment of Cancer Quality of Life Question naire ( EORTC QLQ-30 ) , and the Symptoms of Stress Inventory ( SOSI ) . Results Of the participants , 70.6 % were breast cancer survivors . Mean age was 57.5 years ( treatment group ) and 56.4 years ( control group ) . Between-group demographic differences were not significant ( P > 0.6 ) . The treatment group improved significantly on the EORTC QLQ-30 ( P = 0.005 ) , on six of the eight SOSI subscales ( P ≤ 0.049 ) , and on both SCL-90-R subscales ( P ≤ 0.023 ) , while the control group did not improve on any of these measures ( P > 0.2 ) . Conclusion The MBSR-based cancer recovery and wellness intervention improved the symptoms and quality of life of this largely breast cancer survivor population across a variety of cancer symptoms and quality -of-life measures OBJECTIVE The aims of this study were to compare the quality of life ( QOL ) of women with different cancer sites ; to identify predictors of QOL ; and to examine the agreement between patient self-reported QOL and QOL ratings provided by clinicians and significant others . METHODS A prospect i ve study was conducted including 248 patients with gynecologic and breast cancer . QOL data were collected at six time points before , during , and after treatment , using the EORTC QLQ-C30 and the Spitzer QL index ( QL-I ) . RESULTS Baseline assessment s showed comparable QOL scores among patients with different gynecologic malignancies and breast cancer . During active treatment breast cancer patients had significantly higher mean scores in physical functioning compared to women with gynecologic cancers and higher scores in role functioning compared to patients with cervical cancer . After completion of treatment there were no statistically significant differences in QOL among the groups . For all women , global QOL and emotional functioning were mostly affected during and after treatment . Regression analysis showed that patients ' global QOL was significantly predicted by severity of surgery ( t = 3.903 , P < 0.01 ) and pretreatment performance status ( t = 3.116 , P = < 0.01 ) . Comorbidity , family support , number of treatments , age , and stage of disease were not predictive . The comparison of patient self-rated QOL and observer-rated QOL showed that the QL-I mean scores of health providers and relatives were generally in close agreement with those of patients . Intraclass correlations were moderate to high during active treatment and excellent after completion of treatment . CONCLUSION In female cancer patients , global QOL and emotional functioning are mostly affected during the course of disease , independent of their diagnosis . Significant others and health professionals are able to provide useful information on QOL of patients recovering from cancer The objective of this study was to determine current practice with regards to follow-up after gynecological malignancy . A question naire survey of all lead clinicians in gynecological cancer centers in Engl and was done . The most common duration of routine follow-up was 5 years for all of the main gynecological cancers ( ovarian , endometrial , vulval , and cervical ) . The most common follow-up patterns were three monthly for 2 years then six monthly for 3 years after ovarian cancer ; three monthly for the first year , four monthly for the second year , six monthly for the third year then annually for 1 year after endometrial cancer ; three monthly for the first year , four monthly for the second year , six monthly for the third and fourth years , then annually for 1 year after vulval cancer ; three monthly for the first year , four monthly for the second year , six monthly for the third and fourth years , then annually for 1 year after cervical cancer . The test for CA125 was routinely performed by 67 % of cancer networks to detect recurrence after ovarian cancer . Routine follow-up after gynecological cancer continues to be st and ard practice , despite limited evidence to support its use . Prospect i ve research is needed to determine best practice The aim of this study was to derive population -based norms for women completing the EORTC QLQ-C30 version 1 which is design ed for use with patients who have cancer . The study was conducted using two different question naires : one design ed for use in female patients with breast cancer , the other for those with gynaecological cancers , but both including the EORTC QLQ-C30 . The women were drawn from the Danish Central Population Register without knowledge of their health status and divided at r and om between the two question naires . All procedures for collecting data were identical . The response rate for those receiving the gynaecological cancer ( GS ) question naire was 49 % and it was 71 % for the breast cancer ( BS ) question naire . Detailed comparison between the two sample s revealed several EORTC QLQ-C30 items showing a clear difference in distribution of scores between them . Because of this and the possible bias due to the relative low age-related response rate in GS , only the results from the BS are used for constructing norms . The norms cover all 30 single items on the EORTC QLQ-C30 and the nine derived scales , for women in four 10-year age groups commencing at 30 years and for those aged 70 - 75 . Clear trends in , for example , declining ability to undertake strenuous activity are illustrated and quantified . Levels of certain symptoms , such as pain , are surprisingly high although it is recognized that the population sample d will contain a proportion of women with active disease including cancer . We recommend the use of these norms both as an aid to the clinical assessment of an individual patient , and to assist in the interpretation of clinical trial and longitudinal quality of life data . As a secondary result , we note that a population -based sample will have a lower response rate to a question naire with more questions , especially if many of these extra questions are on sexual issues This study defines the psychometric properties of the European Organisation for Research and Treatment of Cancer ( EORTC ) quality of life ( QOL ) question naire design ed to measure the QOL of patients with ovarian cancer . The ovarian cancer module ( EORTC QLQ-OV28 ) was developed to supplement the EORTC QLQ-C30 . The core question naire and the QLQ-OV28 were prospect ively administered to 368 ovarian cancer patients after they had been treated with radical or debulking surgery followed by chemotherapy . The QLQ-OV28 module assesses abdominal/gastrointestinal symptoms , peripheral neuropathy , other chemotherapy side-effects , hormonal/menopausal symptoms , body image , attitude to disease/treatment and sexual functioning . Question naires were well accepted by patients , baseline compliance rates were 86 % , 72 % provided a second assessment , less than 3 % of the items had missing data . Multi-trait scaling analyses confirmed the hypothesised scales . All hypothesised scales exhibited good psychometric properties . These results support the clinical and psychometric validity of the EORTC QLQ-OV28 module as a supplement to the EORTC QLQ-C30 Output:	AUTHORS ' CONCLUSIONS We found no evidence to make an informed decision about PROMs for follow-up after gynaecological cancer .
MS2698	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background This pilot r and omized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise , spinal manipulation , and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain , a common morbidity of pregnancy . Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy . Once enrolled , they remained in the study until they had their babies . Women were r and omly allocated into one of three treatment groups using opaque envelopes . The treatment schedule paralleled the prenatal care schedule and women received individualized intervention . Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain . Our primary outcome measure was the Rol and Morris Disability Question naire and our secondary outcome measure was the Numeric Pain Rating Scale . Intention to treat analysis was conducted . For the primary analysis , regression was conducted to compare groups on the outcome measure scores . In a secondary responder analysis , difference in proportions of participants in attaining 30 % and 50 % improvement were calculated . Feasibility factors for conducting a future larger trial were also evaluated such as recruitment , compliance to study protocol s , cost , and adverse events . Results Fifty-seven participants were r and omized into the exercise ( n = 22 ) , spinal manipulation ( n = 15 ) , and Neuro Emotional Technique ( n = 20 ) treatment arms . At least 50 % of participants in each treatment group experienced clinical ly meaningful improvement in symptoms for the Rol and Morris Disability Question naire . At least 50 % of the exercise and spinal manipulation participants also experienced clinical ly meaningful improvement for the Numeric Pain Rating Scale . There were no clinical ly meaningful or statistically significant differences between groups in any analysis . Conclusions This pilot study demonstrated feasibility for recruitment , compliance , safety , and affordability for conducting a larger study in the future . Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain , but the study was not powered to detect the between-group differences as statistically significant . Trial registration Clinical Trials.gov ( Identifier : NCT00937365 ) OBJECTIVE Pregnancy-related lumbopelvic pain is a major problem for the majority of pregnant women . Complementary medicine has been used to alleviate pain , and yoga is one of the most commonly chosen alternative methods . The objective of this study was to assess the effectiveness of Hatha yoga in the reduction of lumbopelvic pain in pregnancy . METHODS A r and omized controlled trial with 60 pregnant women ( age range , 14 - 40 years ) who reported lumbopelvic pain at 12 to 32 weeks of gestation was conducted from June 2009 to June 2011 . Pregnant women who had twin pregnancies , had medical restrictions for exercise , used analgesics , and participated in physical therapy were excluded from the study . Pregnant women were divided into two groups : the yoga group , practicing exercises guided by this method , and the postural orientation group , performing st and ardized posture orientation according to instructions provided in a pamphlet . Treatment in each group lasted 10 weeks . A visual analog scale ( VAS ) was used to measure pain intensity . Lumbar pain and posterior pelvic pain provocation tests were used to confirm the presence of pain . Statistical analysis included the Mann-Whitney test , the McNemar test , a paired Wilcoxon test , and analysis of covariance . RESULTS The median pain score was lower in the yoga group ( p<.0058 ) than the postural orientation group . Lumbar pain provocation tests showed a decreased response in relation to posterior pelvic pain provocation tests and a gradual reduction in pain intensity during 10 yoga sessions ( p<.024 ) . CONCLUSIONS The yoga method was more effective at reducing lumbopelvic pain intensity compared with postural orientation OBJECTIVE To investigate the effect of an exercise program , including specific stabilizing exercises , on pain intensity and functional ability in women with pregnancy-related low back pain . METHODS Fifty women between 16 and 24 weeks of pregnancy were recruited at Tygerberg and Paarl Hospitals , Western Cape , South Africa . Twenty-six women were r and omized to a 10-week exercise program and 24 were r and omized as controls . RESULTS Overall , the most frequent type of back pain experienced was lumbar pain ( 36 [ 72.0 % ] ) . Pain intensity ( P=0.76 ) and functional ability ( P=0.29 ) were comparable between the groups on study entry . In the study group , there was a significant improvement in pain intensity ( P<0.01 ) and an improvement in functional ability ( P=0.06 ) at the end of the study . In the control group , there were no significant changes in pain intensity ( P=0.89 ) or functional ability ( P=0.70 ) at the end of the study . CONCLUSION A specific exercise program decreased back pain intensity and increased functional ability during pregnancy in South African women with lumbar and pelvic girdle pain Eighty-four depressed pregnant women were recruited during the second trimester of pregnancy and r and omly assigned to a massage therapy group , a progressive muscle relaxation group or a control group that received st and ard prenatal care alone . These groups were compared to each other and to a non-depressed group at the end of pregnancy . The massage therapy group participants received two 20 min therapy sessions by their significant others each week for 16 weeks of pregnancy , starting during the second trimester . The relaxation group provided themselves with progressive muscle relaxation sessions on the same time schedule . Immediately after the massage therapy sessions on the first and last days of the 16-week period the women reported lower levels of anxiety and depressed mood and less leg and back pain . By the end of the study the massage group had higher dopamine and serotonin levels and lower levels of cortisol and norepinephrine . These changes may have contributed to the reduced fetal activity and the better neonatal outcome for the massage group ( i.e. lesser incidence of prematurity and low birthweight ) , as well as their better performance on the Brazelton Neonatal Behavior Assessment . The data suggest that depressed pregnant women and their offspring can benefit from massage therapy Objective . To study lumbopelvic pain in women r and omized to a regular exercise program during pregnancy in comparison to women receiving st and ard antenatal care . Design . A two‐armed , two‐center , r and omized controlled trial . Setting . St Olavs Hospital , Trondheim University Hospital and Stavanger University Hospital . Population . A total of 855 pregnant women were r and omized to intervention or control groups . Methods . The intervention was a 12 week exercise program , including aerobic and strengthening exercises , conducted between 20 and 36 weeks of pregnancy . One weekly group session was led by physiotherapists , and home exercises were encouraged twice a week . The control group received st and ard antenatal care . Main outcome measures . Self‐reports of lumbopelvic pain and sick leave due to lumbopelvic pain . The data were analysed according to the “ intention‐to‐treat ” principle . Results . There were no significant differences between groups of women reporting lumbopelvic pain at 36 weeks ( 74 vs. 75 % , p=0.76 ) . The proportion of women on sick leave due to lumbopelvic pain was lower in the intervention group ( 22 % vs 31 % , p=0.01 ) . Conclusions . Exercise during pregnancy does not influence the prevalence of lumbopelvic pain , but women offered a regular exercise course seem to h and le the disorder better Background Absence of knowledge of pregnancy-related pelvic girdle pain ( PPGP ) has prompted the start of a large cohort study in the Netherl and s. The objective of this study was to investigate the prevalence and incidence of PPGP , to identify risk factors involved in the onset and to determine the prognosis of pregnancy-related pelvic girdle pain . Methods / design 7,526 pregnant women of the southeast of the Netherl and s participated in a prospect i ve cohort study . During a 2-year period , they were recruited by midwives and gynecologists at 14 weeks of pregnancy . Participants completed a question naire at baseline , at 30 weeks of pregnancy , at 2 weeks after delivery , at 6 months after delivery and at 1 year after delivery . The study uses extensive question naires with questions ranging from physical complaints , limitations in activities , restriction in participation , work situation , demographics , lifestyle , pregnancy-related factors and psychosocial factors . Discussion This large-scale prospect i ve cohort study will provide reliable insights in incidence , prevalence and factors related to etiology and prognosis of pregnancy-related pelvic girdle pain OBJECTIVE Women commonly experience low back pain during pregnancy . We examined whether a multimodal approach of musculoskeletal and obstetric management ( MOM ) was superior to st and ard obstetric care to reduce pain , impairment , and disability in the antepartum period . STUDY DESIGN A prospect i ve , r and omized trial of 169 women was conducted . Baseline evaluation occurred at 24 - 28 weeks ' gestation , with follow-up at 33 weeks ' gestation . Primary outcomes were the Numerical Rating Scale ( NRS ) for pain and the Quebec Disability Question naire ( QDQ ) . Both groups received routine obstetric care . Chiropractic specialists provided manual therapy , stabilization exercises , and patient education to MOM participants . RESULTS The MOM group demonstrated significant mean reductions in Numerical Rating Scale scores ( 5.8 ± 2.2 vs 2.9 ± 2.5 ; P < .001 ) and Quebec Disability Question naire scores ( 4.9 ± 2.2 vs 3.9 ± 2.4 ; P < .001 ) from baseline to follow-up evaluation . The group that received st and ard obstetric care demonstrated no significant improvements . CONCLUSION A multimodal approach to low back and pelvic pain in mid pregnancy benefits patients more than st and ard obstetric care OBJECTIVE To study osteopathic manipulative treatment of back pain and related symptoms during the third trimester of pregnancy . STUDY DESIGN A r and omized , placebo-controlled trial was conducted to compare usual obstetric care and osteopathic manipulative treatment , usual obstetric care and sham ultrasound treatment , and usual obstetric care only . Outcomes included average pain levels and the Rol and -Morris Disability Question naire to assess back-specific functioning . RESULTS Intention-to-treat analyses included 144 subjects . The Rol and -Morris Disability Question naire scores worsened during pregnancy ; however , back-specific functioning deteriorated significantly less in the usual obstetric care and osteopathic manipulative treatment group ( effect size , 0.72 ; 95 % confidence interval , 0.31 - 1.14 ; P = .001 vs usual obstetric care only ; and effect size , 0.35 ; 95 % confidence interval , -0.06 to 0.76 ; P = .09 vs usual obstetric care and sham ultrasound treatment ) . During pregnancy , back pain decreased in the usual obstetric care and osteopathic manipulative treatment group , remained unchanged in the usual obstetric care and sham ultrasound treatment group , and increased in the usual obstetric care only group , although no between-group difference achieved statistical significance . CONCLUSION Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy OBJECTIVE To investigate if water-gymnastics during pregnancy may reduce the intensity of back/low back pain and the number of days on sick-leave . METHODS A prospect i ve , r and omized study . One hundred and twenty-nine women were r and omized to participate in water-gymnastics once a week during the second half of pregnancy and 129 were r and omized to a control group . The women in both groups filled in question naires in gestational weeks 18 , 34 and within the first postpartum week . Every day from week 18 to labor they assessed the intensity of back/low back pain . RESULTS Back pain intensity increased during pregnancy . No excess risk for the pregnancy associated with water-gymnastics was observed . The women participating in water-gymnastics recorded a lower intensity of back/low back pain . The total number of days on sick-leave because of back/low back pain was 982 in the water-gymnastics group ( 124 women ) compared with 1484 in the control group ( 120 women ) . After weeks 32 33 , seven women in the water-gymnastics group compared with 17 in the control group were on sickleave because of back/ low back pain ( p=0.031 ) . CONCLUSIONS Intensity of back/low back pain increased with advancing pregnancy . There was no excess risk for urinary or vaginal infections associated with water-gymnastics . Water-gymnastics during the second half of pregnancy significantly reduced the intensity of back/ low back pain . Water-gymnastics decreased the number of women on sick-leave because of back/low back pain . Water-gymnastics during pregnancy can be recommended as a method to relieve back pain and may reduce the need for sick-leave Lower back pain and lordosis are among the most common complications during pregnancy ; their frequency in pregnant women is 4 times that in non-pregnant women [ 1 ] . The present study evaluated the effect of exercise on back pain during pregnancy . Inclusion criteria were maternal age of 20–30 years ; nulliparity ; gestational age of 16 weeks ( according to reliable last Output:	All included studies on exercise therapy , and most of the studies on interventions combined with patient education , reported a positive effect on pain , disability , and /or sick leave .
MS2699	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The purpose of this statement is to up date the recommendations by the American Heart Association ( AHA ) for the prevention of infective endocarditis that were last published in 1997 . METHODS AND RESULTS A writing group was appointed by the AHA for their expertise in prevention and treatment of infective endocarditis , with liaison members representing the American Dental Association , the Infectious Diseases Society of America , and the American Academy of Pediatrics . The writing group review ed input from national and international experts on infective endocarditis . The recommendations in this document reflect analyses of relevant literature regarding procedure-related bacteremia and infective endocarditis , in vitro susceptibility data of the most common microorganisms that cause infective endocarditis , results of prophylactic studies in animal models of experimental endocarditis , and retrospective and prospect i ve studies of prevention of infective endocarditis . MEDLINE data base search es from 1950 to 2006 were done for English- language papers using the following search terms : endocarditis , infective endocarditis , prophylaxis , prevention , antibiotic , antimicrobial , pathogens , organisms , dental , gastrointestinal , genitourinary , streptococcus , enterococcus , staphylococcus , respiratory , dental surgery , pathogenesis , vaccine , immunization , and bacteremia . The reference lists of the identified papers were also search ed . We also search ed the AHA online library . The American College of Cardiology/AHA classification of recommendations and levels of evidence for practice guidelines were used . The paper was subsequently review ed by outside experts not affiliated with the writing group and by the AHA Science Advisory and Coordinating Committee . CONCLUSIONS The major changes in the up date d recommendations include the following : ( 1 ) The Committee concluded that only an extremely small number of cases of infective endocarditis might be prevented by antibiotic prophylaxis for dental procedures even if such prophylactic therapy were 100 % effective . ( 2 ) Infective endocarditis prophylaxis for dental procedures is reasonable only for patients with underlying cardiac conditions associated with the highest risk of adverse outcome from infective endocarditis . ( 3 ) For patients with these underlying cardiac conditions , prophylaxis is reasonable for all dental procedures that involve manipulation of gingival tissue or the periapical region of teeth or perforation of the oral mucosa . ( 4 ) Prophylaxis is not recommended based solely on an increased lifetime risk of acquisition of infective endocarditis . ( 5 ) Administration of antibiotics solely to prevent endocarditis is not recommended for patients who undergo a genitourinary or gastrointestinal tract procedure . These changes are intended to define more clearly when infective endocarditis prophylaxis is or is not recommended and to provide more uniform and consistent global recommendations Introduction : The study aim ed at evaluating the effect of chlorhexidine ( CHX ) in preventing plaque biofilm ( PB ) formation on healing abutments ( HAs ) in patients rehabilitated with osseointegrated implants . Material s and Methods : Fifty HAs were placed in 34 voluntary patients 1 week after implant surgery ( test group ) . After 7 days , a new set of 50 HAs was placed in the same implant sites and removed 1 week after ( control group ) . During the 2 testing periods , patients were instructed to apply : CHX mouth rinsing twice daily and no brushing ( test ) ; no CHX mouth rinsing and no brushing ( control ) . Scanning electron microscopy and image analysis were blindly used to objective ly quantify PB amount on removed HAs . Results : Median values and interquartile ranges of the percent ratio of titanium surface covered from PB were 0.9 ( 0.1–4.1 ) and 1.2 ( 0.1–11.6 ) for test and control groups , respectively ( P = 0.0275 ) . Conclusions : CHX mouth rinsing significantly limited plaque formation on HAs , being a valid contribution to mechanical brushing in early phases of plaque control on dental implants There are many reasons for dental implant failure , the development of bacteremia is concern for dentists . This is due to the possibility of unfavorable result such as implant loss or the need for re-treatment . In general , antibiotic prophylaxis is recommended for high risk patients such as individuals with an immunodeficiency , infectious endocarditis , or previous prosthetic instrumentation . However regarding clinical ly healthy , low and moderate risk individuals the use of antibiotics in implant dentistry is controversial . Another major concern regarding the over prescription of antibiotics is the selection of antibiotic resistant bacteria . A better underst and ing of the efficacy of prophylactic treatments regarding dental implantation is crucial . Thus a literature review and comparison of survival rates of dental implants with regimens of no , pre or post prophylaxis was performed using systematic literature review using reliable electronic data bases . Retrospective or prospect i ve controlled studies were examined for the influence of preoperative and /or postoperative or no antibiosis on dental implant success rate . Of the 11406 implants used in this literature review , cases with no antibiotics had a 92 % success rate , cases with pre-op antibiotic alone had a 96 % success rate , cases with post-op antibiotic alone had a 97 % success rate and cases with both pre and post-op antibiotic had a success rate of 96 % . Thus , the results from this literature review show a > 90 % success rate when antibiotics are used compared to when they are not used . Thus , no benefit is seen from the use of antibiotic prophylaxis in low and moderate risk dental implant patients . Keywords Dental implants ; Pre-operative prophylactics ; Post-operative prophylactics ; Success The purpose of this study was to compare the efficacy of two antibiotic regimens in reducing early dental implant failure . A preoperative single-dose regimen and a 3-day antibiotic course were compared . Eighty subjects needing dental implant placement were r and omly allocated to one of the two antibiotic prophylaxis regimen groups . In the first group , dental implants were placed after the administration of a single preoperative dose of antibiotic ( 1 g of amoxicillin ) ; no postoperative antibiotics were given . In the second group , dental implants were inserted in patients who received the same preoperative dose of antibiotic as the first group , but the antibiotic was then continued postoperatively for 3 days . Patients returned for postoperative evaluation at 3 days , 7 days , and 12 weeks . The surgical sites were assessed for pain , swelling , wound dehiscence , and pus formation . No statistically significant difference was observed between the two groups , probably because of the limited number of patients . Although minor complications were seen in a few patients , all implants were successfully osseointegrated . Until a study with a larger population rules definitively on the role of antibiotics in implant surgery , a single dose of antibiotic before implant placement may be sufficient OBJECTIVES This r and omized clinical trial compares the usefulness of pre- and post-operative antibiotics while strict asepsis was followed during periodontal surgery . MATERIAL AND METHODS Two groups of 40 consecutive patients each with fully or partially edentulous jaws were enrolled . Antibiotics group ( GrAB(+ ) ) : 23 men , mean age 60 , 128 implants , received oral amoxicillin 1 g , 1 h pre-operatively and 2 g for 2 days post-operatively . Non-antibiotics group ( GrAB(- ) ) : 20 men , mean age 57 , 119 implants , received no antibiotics . Bacterial sample s were taken from the peri-oral skin before and at the end of surgery . In 12 patients in each group , sample s were also taken from the nares . A VAS question naire evaluated symptoms of infection/inflammation by both the patient and the periodontologist at suture removal . RESULTS There were no significant differences between both groups , neither for the clinical parameters nor for the microbiota . Staphylococcus aureus was detected in the nares of one patient only . The patients ' subjective perception of post-operative discomfort was significantly smaller in the group receiving antibiotics . Three patients lost one or two implants . CONCLUSIONS Antibiotics do not provide significant advantages concerning post-operative infections in case of proper asepsis . It also does not reduce peri-oral microbial contamination . It does on the other h and reduce post-operative discomfort PURPOSE To evaluate the efficacy of prophylactic antibiotics for dental implant placement . MATERIAL S AND METHODS Twelve Italian private practice s agreed to participate in this trial , each centre providing 30 patients . One hour prior to implant placement , patients were r and omised , for consumption orally of 2 g amoxicillin or identical placebo tablets . Patients needing bone augmentation procedures were not included . Outcome measures were prosthesis and implant failures , adverse events and post-operative biological complications . Patients were seen 1 week , 2 weeks and 4 months post-operatively . RESULTS One centre did not deliver any data and 14 patients had to be excluded from the trial for various reasons . One hundred and fifty-eight patients were evaluated in each group and none dropped out at 4 months . Two prostheses and two implants failed in the antibiotics group , compared with four prostheses and nine implants in the placebo group . There were no statistically significant differences for prosthesis failures , implant losses , complications and side effects . CONCLUSIONS No statistically significant differences were observed . However , four times more patients in the placebo group experienced implant failures than in the antibiotic group , and this requires further investigation PURPOSE To evaluate the difference between a single preoperative dose versus an additional two-day postoperative course of oral amoxicillin in patients undergoing conventional dental implant placement . MATERIAL S AND METHODS Two dentists in two different private practice s conducted this study . One hour prior to surgery , patients had to take a single prophylactic antibiotic dose , consisting of 2 g of amoxicillin orally ; after implant placement , patients were r and omly allocated to two different groups : protocol A ( no other antibiotic administration ) and protocol B , ( 1 g of amoxicillin in the evening of the day of surgery and 1 g twice a day for the 2 days after ) . Outcome measures were prosthetic and implant failures , adverse events and early postoperative complications . Patients were followed up to 6 months after functional loading . RESULTS Three hundred and sixty patients were r and omised and treated ( 192 patients in one centre and 168 in the other ) . Five hundred and sixty-seven implants were placed . Protocol A was applied to 180 patients ( 278 implants ) and protocol B also to 180 patients ( 289 implants ) . Data for 17 patients , 14 from protocol A and three from protocol B , were not available . No statistically significant differences were found for the reported outcomes . Two patients of protocol B experienced a prosthetic failure , losing four implants , while no prosthetic failures were reported for protocol A ( P=0.4836 ; difference in proportions=-0.0110 ; 95 % CI : -0.0412 to 0.0119 ) . Five patients ( 3.0 % ) of protocol A lost five implants versus 5 patients ( 2.8 % ) who lost eight implants in protocol B ( P=1.0000 ; difference in proportions=0.0020 ; 95 % CI : -0.0384 to 0.0438 ) . Three adverse events were observed in the total population , all occurring in protocol B ( 1.69 % ) , with no statistically significant differences between the two groups ( P=0.1199 ; difference in proportions=-0.0170 ; 95 % CI : -0.0487 to 0.0059 ) . However , one patient experienced a severe allergic reaction requiring therapy discontinuation and hospital admission . Early postoperative complications occurred in six patients of protocol A and in four patients of protocol B , with no statistically significant differences ( P=0.5170 ; difference in proportions=0.0130 ; 95 % CI : -0.0254 to 0.0568 ) . CONCLUSIONS No statistically significant differences were observed between 2 g of preoperative amoxicillin and an additional 2-day postoperative course , although adverse events were reported only in the additional 2-day postoperative group . Based on these findings , it might be sufficient to routinely administer preoperatively 2 g of amoxicillin to patients undergoing routine dental implant placement procedures rather than administering additional postoperative doses AIM The aim of this prospect i ve cohort study was to evaluate an anti-infective surgical protocol for the treatment of peri-implantitis . MATERIAL S AND METHODS Thirty-six implants in 24 partially dentate patients with moderate to advanced peri-implantitis were treated using an anti-infective surgical protocol incorporating open flap debridement and implant surface decontamination , with adjunctive systemic amoxicillin and metronidazole . Treatment outcomes were assessed at 3 , 6 and 12 months . Patient-based statistical analyses using multiple regression analyses were performed . RESULTS There was 100 % survival of treated implants at 12 months . At 3 months , there were statistically significant ( P < 0.01 ) reductions in mean probing depths ( PD ) , Bleeding on Probing ( BoP ) and suppuration . The greater the mean PD at baseline , the greater the PD reduction at 3 months . At 3 months , there Output:	In conclusion , antibiotic use in healthy patients for the prophylaxis of surgical infection associated with dental implant placement does not appear to improve clinical outcomes .

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.